PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG

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

IT WAS REPORTED THAT DURING DELIVERY THROUGH THE VESSEL OF A PROTEGE EVERFLEX STENT TO THE COMMON ILIAC ARTERY, THE CATHETER BROKE OR FRACTURED AND THE DELIVERY SYSTEM WAS REPORTED TO BE DAMAGED. THE LESION WAS PRE-DILATED USING A 5 MM BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER STENT. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY AND NO SYMPTOMS OR COMPLICATIONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.