PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

DURING THE INDEX PROCEDURE A PROTEGE EVERFLEX OTW STENT (ON (B)(6) 2016) WAS USED TO TREAT THE RIGHT SFA. APPROXIMATELY NINE (9) YEARS POST INDEX PROCEDURE THE PATIENT HAD A PVD FOLLOW-UP (ON (B)(6) 2025) STATING LIFESTYLE LIMITING CLAUDICATION OF BOTH LEGS. THE PATIENT ALSO EXPERIENCED SHARP PAINS IN BILATERAL THIGHS ULTRASOUND REVEALED SUFFERED IN-STENT RESTENOSIS IN THE TARGET LESION RIGHT SFA (ON (B)(6) 2025). THE EVENT WAS TREATED WITH AN 6X40 IN.PACT ADMIRAL DCB. THE PATIENT RECOVERED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.