Endurant Endografts

NON COMPETITIVE MEMORANDUM FOR ACTIONS UNDER THE SAT IAW FAR 13.106-3(b)(i) AND AFFARS 5313.106-1(b)(3) 1. REQUIRING AGENCY - AFTC/PZIOAC, Eglin AFB, Florida 2. NATURE/DESCRIPTION OF ACTION BEING APPROVED - Sole source acquisition of Medtronic Endurant Endografts 3. DESCRIPTION OF SUPPLIES OR SERVICES REQUIRED TO MEET THE AGENCY'S NEEDS -Eglin AFB 96th MDG requires these endografts in order to perform surgery on a patient, who was suffering from blockage to their aortic artery. 4. IDENTIFICATION OF STATUTORY AUTHORITY PERMITTING OTHER THAN FULL AND OPEN COMPETITION - 10 U.S.C. 2304(C)(2) 5. DEMONSTRATION THAT THE PROPOSED CONTRACTOR'S UNIQUE QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES USE OF THE AUTHORITY CITED: Currently Medtronic Endurant Endografts are the only product on the market that has the safety mechanism of a Reliant Balloon that allows the surgeon to partially deploy the graft. This safety mechanism differs from its competitors because it gives the surgeon the freedom to realign and/or move the graft safely to the appropriate area of concern without fully deploying the graft. The competitors do not provide this safety option of placement, once deployed there is no way to correct or better place the graft. 6. DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE SOLICITED FROM AS MANY POTENTIAL SOURCES AS PRACTICABLE: This requirement was exempt from being synopsized under FAR 5.202(a)(2). 7. DETERMINATION BY THE CONTRACTING OFFICER THAT THE ANTICIPATED COST TO THE GOVERNMENT WILL BE FAIR AND REASONABLE: In determining the price to be fair and reasonable, a comparison of price for the Endurant Endografts was made with previous purchases by the Department of Defense Agencies. Contract # Location Contractor Total Cost FA2823-13-P-XXXX Eglin AFB Medtronic, Inc. $30,740.00 FA3047-08-P-XXXX Lackland AFB Medtronic, Inc. $29,025.00 N00168-13-P-XXXX Walter Reed Medtronic, Inc. $34,700.00 The total cost of the endovascular repair is $30,740.00 made by Medtronic Inc., therefore the proposed price to the government is considered fair and reasonable with (IAW) FAR 13.106-3(a)(2)(ii)and(vii). 8. A DESCRIPTION OF MARKET RESEARCH CONDUCTED AND THE RESULTS After searching FPDS-NG and EDA for this requirement it was identify that only company Medtronic Inc. can supply the items required. Currently Medtronic is the only company that is FDA approved to manufacture a 1 centimeter neck requiring less graft area. Appropriate graft size is absolutely critical to the success of a procedure of this magnitude. The surgeon decides on the size needed based on the patient's anatomy and size of the aneurism. If the size is off by the smallest measurement, a severe rupture or hemorrhage may occur possibly causing death. 9. ANY OTHER FACT SUPPORTING THE USE OF OTHER THAN FULL AND OPEN COMPETITION: This requirement was a mission impact; a patient had been suffering from a blockage to his aortic artery and was in need of urgent aortagram to observe the extent of the injury. By providing the Medtronic Endurant Endografts secured the care for the patient under unexpected yet possible trauma care and helped prevent any loss of limbs or embolisms. The requirement helped restore blood circulation to the patient's legs giving him a better chance of a successful treatment and a speedy recovery. 10. A LIST OF SOURCES THAT EXPRESSED IN WRITING AN INTEREST IN THE ACQUISITION: None 11. ACTIONS TO REMOVE OR OVERCOME ANY BARRIERS TO COMPETITION BEFORE ANY SUBSEQUENT ACQUISITIONS: This was an unfortunate situation and there are no known actions actions to prevent a recurrence. I certify that the facts contained in this justification are complete and accurate to the best of my knowledge.