BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT

    MDR report key: 3140205 · Received May 31, 2013

    Report

    Report Number
    2953200-2013-01031
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 4, 2013
    Report Date
    July 1, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CONCLUSIONS: (UNKNOWN CAUSE OF EVENT).

    Additional Manufacturer Narrative · 1

    RESULTS, CONCLUSION: UNKNOWN CAUSE OF EVENTS.

    Description of Event or Problem · 1

    AN ENDURANT AORTIC CUFF WAS IMPLANTED IN A PATIENT THAT WAS TREATED WITH ANOTHER MANUFACTURER¿S BIFURCATED STENT GRAFT THAT HAD MIGRATED DISTALLY WITH A PROXIMAL TYPE I ENDOLEAK DURING AN EMERGENT ENDOVASCULAR TREATMENT OF A CONTAINED 5 CM IN DIAMETER RUPTURED ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE REPORTED NON-TORTUOUS AND NON-CALCIFIED. IT WAS REPORTED THERE WERE NO ABNORMALITIES NOTED DURING THE PREPARATION OF THE DEVICE AND THAT THE DELIVERY SYSTEM WAS INSERTED INTO THE PATIENT WITHOUT DIFFICULTY. DURING THE DEPLOYMENT OF THE STENT GRAFT, THE PHYSICIAN ROTATED THE EXTERNAL SLIDER BACK PROXIMATELY 3-4 CM FROM THE GREY FRONT GRIP WHEN THE PHYSICIAN NOTICED THE GRAFT COVER WAS NO LONGER ADVANCING. THE SCREW GEAR WAS OBSERVED TO HAVE A BREAK TRANSVERSE THE SCREW GEAR. THE PHYSICIAN ELECTED TO FURTHER BREAK OFF THE DISTAL END OF THE DELIVERY SYSTEM, WHICH ALLOWED THE EXTERNAL SLIDER TO ADVANCE PAST THE BROKEN SECTION OF THE SCREW GEAR AND SUCCESSFULLY DEPLOY THE ENDURANT CUFF. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    THE DEVICE EVALUATION HAS BEEN COMPLETED FOR THIS CASE. THE EXTERNAL SLIDER WAS SEPARATED INTO TWO HALVES AND PLACED IN ITS HOME POSITION, ADJACENT TO THE FRONT GRIP. THE BREAK IN THE SCREWGEAR ALIGNED WITH THE VERY PROXIMAL ASPECT OF THE EXTERNAL SLIDER; WHEN BOTH HALVES OF THE EXTERNAL SLIDER WERE IN PLACE, THE BREAK ON ONE HALF COULD NOT BE SEEN; THE LOCATION OF THE BREAK WOULD MAKE IT DIFFICULT TO BE OBSERVED PRIOR TO USE. WHEN THE SECTIONS OF THE SCREWGEAR WERE ALIGNED WITH THEIR CORRESPONDING HALVES, ONE HALF WAS NOTED TO HAVE A SMALL PIECE OF MATERIAL MISSING. THE COMPLAINT WAS CONFIRMED; THE SCREWGEAR WAS BROKEN AT THE PROXIMAL/BACKEND OF THE EXTERNAL SLIDER. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED; THE DAMAGE MAY HAVE OCCURRED DURING SHIPMENT/RECEIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241982 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00965879

    Patients

    Seq Age Sex Outcome Treatment
    1