BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II EXTENSION CUFF

    MDR report key: 20064496 · Received August 26, 2024

    Report

    Report Number
    9612164-2024-03862
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 31, 2024
    Report Date
    September 2, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    UDI-DI
    00613994991461
    PMA / PMN Number
    THIS IS A SY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: THIS IS A SYSTEM REPORT. THE SECTION D INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOWING: PRODUCT ID: ETCF3636C49E, SERIAL/LOT #: (B)(6), UBD: 03-MAY-2026, UDI#: (B)(4). 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: IN REFERENCE TO BOTH ENDURANT CUFFS IMPLANTED, IT WAS CONFIRMED THE TYPE IA ENDOLEAK WAS ONLY ASSOCIATED WITH THE PROXIMALLY IMPLANTED CUFF ETCF3636C49E (B)(6). THEREFORE THERE IS NO INFORMATION TO REASONABLE SUGGEST THAT THE DEVICE PREVIOUSLY SYSTEM REPORTED DEVICE PRODUCT ID; ETCF3636C49E; SERIAL NUMBER: (B)(6) MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. THEREFORE THIS DEVICE DOES NOT MEET REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. 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 · 0

    AN ANEURX STENT GRAFT SYSTEM AND EXTENSION CUFF WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA. IT WAS REPORTED APPROXIMATELY 16 YEARS POST THE INDEX PROCEDURE, FOLLOW-UP CT SHOWED BOTH EXISTING PROXIMAL STENT GRAFTS HAD MIGRATED DUE TO NECK EXPANSION LEADING TO A TYPE IA ENDOLEAK. INTERVENTION WAS PERFORMED. A ENDURANT CUFF ETCF3636C49E (V31180196) WAS DEPLOYED WITHOUT INCIDENT, LANDING JUST DISTAL TO THE ORIGIN OF THE RENAL ARTERIES. HELI-FX ENDOANCHORS WERE THEN DEPLOYED SA-85 (LOT #0011791286) 2 ENDOANCHORS WERE DEPLOYED WITHOUT INCIDENT. DURING THE DEPLOYMENT OF THE 3RD ENDOANCHOR THE INITIAL STEP OF DEPLOYMENT WAS PERFORMED WITHOUT INCIDENT AS THE ENDOANCHOR SUCCESSFULLY ENGAGED AND PENETRATED THE STENT GRAFT FABRIC IN THE CORRECT ORIENTATION, HOWEVER, DURING THE SECOND STEP, THE ENDOANCHOR APPEARED TO CHANGE ORIENTATION. THE 3RD ENDOANCHOR HAD TO BE REPOSITIONED SEVERAL TIMES. IT HAS APPEARED THAT THE ENDOANCHOR INTERACTED WITH CALCIUM DURING THE FINAL STAGE DEPLOYMENT. THE SA-85 WOULD NOT LOAD THE 4TH ENDOANCHOR AND DAMAGE TO THE TIP OF THE SA-85 WAS SUSPECTED. A SECOND SA-85 (LOT # 0011823330) WAS OPENED AND 3 MORE ENDOANCHORS WERE DEPLOYED WITHOUT INCIDENT. THE PHYSICIAN DECIDED TO IMPLANT A SECOND CUFF ETCF3636C49E (V31411361) TO EXTEND 10MM LOWER THAN THE FIRST TO PROVIDE MORE DISTAL OVERLAP WITH THE BIFURCATED ANEURX GRAFT. A SUSPECTED TYPE IA ENDOLEAK WAS STILL OBSERVED, THE PHYSICIAN DECIDED TO END THE CASE AND REEVALUATE. PER THE PHYSICIAN THE CAUSE IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276427 ENDURANT II EXTENSION CUFF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ETCF3636C49E 00613994991461

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male "SEE H11...."