BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2974282 · Received February 22, 2013

    Report

    Report Number
    2953200-2013-00317
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: (FILM). RESULTS: INHERENT RISK OF PROCEDURE (REMOVAL DIFFICULTIES); CAUSED BY ANOTHER DRUG/DEVICE (AORTA BI-FEM GRAFT); FAILURE TO FOLLOW INSTRUCTIONS (AORTIC CUFF STENT GRAFT WAS IMPLANTED WITHOUT A BIFURCATED STENT GRAFT). CONCLUSION: ANOTHER DEVICE CAUSED FAILURE (AORTA BI-FEM GRAFT); OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (AORTIC CUFF STENT GRAFT WAS IMPLANTED WITHOUT A BIFURCATED STENT GRAFT).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 67 MM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. THE AORTIC NECK WAS 23 MM IN DIAMETER AND 33 MM IN LENGTH. THE RIGHT ACCESS SITE DIAMETER WAS 13MM. THE PATIENT HAD A PREVIOUSLY IMPLANTED AORTA BI-FEM GRAFT. THE LEFT LEG HAD A VIABAHN THAT OVERLAPPED WITH THE LEFT LEG OF THE AORTA BI-FEM. THE AORTO BI-FEM GRAFT SIZES INCLUDE: DISTAL GRAFT DIAMETER BEFORE IT BIFURCATES 24MM; RIGHT GRAFT DIAMETER 13-14MM; LEFT GRAFT DIAMETER 13-14MM; AND LEIA VIABAHN FLOW LUMEN DIAMETER 5.5MM. ONLY AN ENDURANT AORTIC CUFF WAS 282870 WAS IMPLANTED. IT WAS REPORTED THAT THE VIABAHN APPEARED TO BE CRUSHED OR HAD SOME IN-FOLDING. THE LEFT SIDE OF THE PATIENT ALSO HAD A HEMATOMA. THE PHYSICIAN DID NOT WANT TO ACCESS THE LEFT SIDE AND MADE A CUT DOWN ON THE RIGHT. THERE WAS DIFFICULTY GETTING THE DEVICE IN SO THE RIGHT ILIAC WAS DILATED WITH A 14FR SHEATH/DILATOR. THEN THE ENDURANT CUFF WAS INSERTED, POSITIONED PROXIMAL TO THE AORTO BI-FEM, AND DEPLOYED. THE TIP WAS CLOSED DOWN AND THE PHYSICIAN PULLED FRONT OF THE HANDLE BACK TO MAKE A GOOD TRANSITION ON THE WAY OUT BUT FELT SOME RESISTANCE WHEN PULLING THE DEVICE OUT DOWN THROUGH THE RIGHT ILIAC ARTERY. AT THIS POINT THE TAPERED TIP WAS FOUND TO HAVE PULLED OFF OF THE DELIVERY SYSTEM. IT TOOK FOUR HOURS FOR THE PHYSICIAN TO SNARE THE TIP OUT OF THE PATIENT WITHOUT HAVING TO SURGICALLY OPEN THE PATIENT. IN THE PROCESS OF REMOVING THE TIP, THE SUPRA-RENAL STENTS WERE MANIPULATED AND SOME OF THEM WERE BENT DOWN AND OUT OF THEIR ORIGINAL POSITION. NO FINAL ANGIO RUNS WERE DONE AT THE END OF THE CASE. THE PATIENT IS DOING FINE. REVIEW OF RETURNED FILMS PRE-IMPLANT SHOW A 6CM AAA. THERE IS AN AORTO-BI-FEMORAL GRAFT PLACED IN THE DISTAL AAA SAC. THE DIAMETER OF THE GRAFT, PRIOR TO THE BIFURCATION, MEASURES 1.7CM X 2.5CM. THE RIGHT ILIAC GRAFT FLOW LUMEN ID IS 1.4CM, AND 0.9CM IN THE LEFT ILIAC GRAFT. JUST DISTAL TO THE BIFURCATION THE RIGHT ILIAC GRAFT IS SLIGHTLY ANGULATED, BUT THEN COURSES STRAIGHT DISTALLY. THE VIABAHN STENT APPEARS CRUSHED TO LESS THAN 5MM ID IN THE LEFT FEMORAL. IMAGES DURING IMPLANT OR POST-IMPLANT WERE NOT PROVIDED; THE CAUSE OF THE TIP DETACHMENT COULD NOT BE DETERMINED. IT IS POSSIBLE THAT UNKNOWN ISSUES OCCURRING DURING DELIVERY SYSTEM REMOVAL WITHIN THE PREVIOUSLY IMPLANTED GRAFT MAY HAVE CONTRIBUTED.

    Description of Event or Problem · 1

    THE DEVICE EVALUATION HAS BEEN COMPLETED. THE DEVICE WAS RETURNED BLOODIED. UPON INVESTIGATION OF THE DELIVERY SYSTEM, IT WAS NOTED THAT THE TAPERED TIP WITH SLEEVE HAD SEPARATED FROM THE SPINDLE. THE TAPERED TIP SEPARATED FROM THE TAPERED TIP INSERT; THE METAL COMPONENT DISTAL TO THE SPINDLE ON TO WHICH THE TAPERED TIP IS OVERMOLDED. ON THE PROXIMAL EDGE OF THIS INSERT, REMNANTS OF THE PEBAX MATERIAL WERE NOTED. THE TAPERED TIP MEASURED 70 MM FROM THE DISTAL TIP THE END OF THE SLEEVE. THE DISTAL EDGE OF THE TAPERED TIP HAD A SMALL CUT/SLIT. THE PROXIMAL, WIDEST SECTION OF THE TAPERED TIP ALSO HAD SEVERAL EVENLY SPACED STRIATIONS, WHICH MAY HAVE BEEN CAUSED BY HEMOSTATS. THERE WAS ALSO A LARGE DENT/DIVOT ON ONE SIDE OF THE TAPERED TIP SLEEVE. THE ID OF THE THROUGH HOLE OF THE TAPERED TIP AND THE OD OF THE TAPERED TIP WERE WITHIN SPECIFICATION. THE ROOT CAUSE COULD NOT BE DETERMINED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77684 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00954637

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention