BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO ANCHOR SYSTEM - HELI-FX AAA

    MDR report key: 9502261 · Received December 20, 2019

    Report

    Report Number
    9612164-2019-05258
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    December 16, 2019
    Report Date
    February 27, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    OTD
    PMA / PMN Number
    K140036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT PART OF THE BROKEN ENDOANCHOR REMAINS IN THE PATIENTS AORTIC WALL. THE REMAINING HALF OF THE ENDOANCHOR WAS IN THE SA-85 WHICH WAS SUBSEQUENTLY DISCARDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS SUMMARY: THE REPORTED ANCHOR FRACTURE WAS CONFIRMED; HOWEVER, THE CAUSE OF THE FRACTURE COULD NOT BE DETERMINED FROM THE LIMITED STILL IMAGES DURING IMPLANT AND THE SINGLE SITE PHOTOGRAPH OF THE FRACTURED ENDOANCHOR. THE FRACTURED ANCHOR WAS NOT RETURNED FOR A MORE DETAILED ANALYSIS; INCLUDING SEM ANALYSIS. ADDITIONAL IMAGES DURING IMPLANT, INCLUDING FILMS DURING IMPLANT OF THE HELI-FX ENDOANCHOR WHEN THE FRACTURE OCCURRED, WERE ALSO NOT AVAILABLE FOR REVIEW. OTHER THAN THE THROMBUS OBSERVED WITHIN THE BARREL-SHAPED PROXIMAL NECK, ANALYSIS OF THE RETURNED PRE-IMPLANT FILMS DID NOT REVEAL ANY OTHER ANATOMICAL CHARACTERISTICS THAT COULD EXPLAIN THE REPORTED EVENT. POSSIBLE ANATOMICAL CAUSES OF THE ANCHOR FRACTURE INCLUDE IMPLANTING INTO AREAS OF CALCIFICATION, THROMBUS, AND HIGHLY ANGULATED ANATOMY. IN ADDITION, IMPROPER APPOSITION, EXCESSIVE CATHETER TORQUE BUILD-UP, ENGAGING MULTIPLE FABRIC LAYERS, AND EXCESSIVE UNSUPPORTED APPLIER MAY HAVE ALSO CONTRIBUTED TO THE ANCHOR FRACTURE. A DEVICE ISSUE CANNOT BE RULED OUT AS A POTENTIAL CAUSE. HOWEVER, THE DELIVERY SYSTEM WAS DISCARDED AND A PRODUCT INVESTIGATION COULD NOT BE PERFORMED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HELI-FX ENDOANCHOR SYSTEM WAS USED IN THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM. AN ENDURANT IIS STENT GRAFT SYSTEM WAS ALSO IMPLANTED DURING THE PROCEDURE AND THE ENDOANCHORS WERE IMPLANTED PROPHYLACTICALLY IN THE BIFURCATED STENT GRAFT. IT WAS REPORTED THE PATIENT HAD MODERATE PROXIMAL NECK THROMBUS. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE ONE OF THE HELI-FX ENDOANCHORS BROKE DURING ITS IMPLANTATION. IT IS REPORTED THAT WHEN THE PHYSICIAN PRESSED THE FORWARD BUTTON ON THE SECOND OCCASION, THE SA-85 APPLIER JUMPED AND THE BROKEN ENDOANCHOR WAS NOTED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS PRODUCT RELATED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300851 ENDO ANCHOR SYSTEM - HELI-FX AAA ENDOVASCULAR SUTURING SYSTEM OTD MEDTRONIC IRELAND SA-85 0009065479

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR