BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II ILIAC STENT GRAFT

    MDR report key: 6172205 · Received December 13, 2016

    Report

    Report Number
    2953200-2016-02113
    Event Type
    Death
    Date Received
    December 13, 2016
    Date of Event
    December 7, 2016
    Report Date
    February 27, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    UDI-DI
    00643169467590
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ETLW1613C93E, SN (B)(4), EXPIRATION DATE: 2017-12-08, UDI # (B)(4); ETLW1616C82E, SN (B)(4), EXPIRATION DATE: 2018-07-20, UDI # (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). FILM EVALUATION SUMMARY: THE CAUSE AND SOURCE OF THE POST-IMPLANT RUPTURE COULD NOT BE DETERMINED FROM THE LIMITED STILL ANGIO IMAGES PROVIDED. THE FILMS SHOWED CONTRAST BLUSH PRIMARILY COMING FROM THE RIGHT SIDE NEAR THE LEVEL OF THE FLOW DIVIDER; HOWEVER, CONTRAST WAS ALSO SEEN ALONG THE LEFT SIDE OF THE AORTIC BODY AND FROM THE GATE. IT APPEARS MOST LIKELY THAT THE ENDOLEAK WAS AN ACUTE TYPE IV ENDOLEAK CAUSED BY FABRIC POROSITY. THE PATIENT'S REPORTED INABILITY TO FORM A CLOT ALSO LIKELY CONTRIBUTED TO THE LIKELY TYPE IV. THERE APPEARED TO BE LESS THAN RECOMMENDED CONTRA LIMB OVERLAP WITHIN THE GATE, SO IT IS POSSIBLE THAT THERE WAS ALSO A TYPE III JUNCTIONAL ENDOLEAK. OTHER FACTORS SUCH AS HEPARIN DOSE, OUTFLOW RESISTANCE, AND VOLUME OF THE ANEURYSM SAC MAY HAVE ALSO CONTRIBUTED TO THIS TYPE IV ENDOLEAK.

    Description of Event or Problem · 1

    AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR AN EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AFTER THE ENDOVASCULAR AORTIC REPAIR HAD BEEN PERFORMED THE PHYSICIAN NOTED THAT THE PATIENT¿S ABDOMEN HAD BECOME ENLARGED. THE PHYSICIAN ELECTED TO BRING THE PATIENT TO THE OPERATING ROOM AND PERFORM EXPLORATORY SURGERY AND THEN AN OPEN REPAIR. THE PHYSICIAN OBSERVED THAT THE ENDURANT IIS BIFURCATE HAD A TYPE IV ENDOLEAK. ADDITIONALLY, TYPE III SEPARATION ENDOLEAKS WERE OBSERVED AT EVERY STENT GRAFT OVERLAP JUNCTION. THE PATIENT EXPIRED DUE TO CARDIAC ARREST DURING THE OPEN REPAIR. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS RELATED TO THE DEVICE AND TO THE PATIENT¿S INABILITY TO FORM A CLOT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ANEURYSM WAS THOUGHT TO HAVE BEEN EXCLUDED AT THE END OF THE IMPLANT PROCEDURE. IT WAS CLARIFIED THAT THERE WAS NO TYPE III SEPARATION ENDOLEAK OBSERVED DURING THE IMPLANT PROCEDURE; THE ENDOLEAK SEEN AT EACH JUNCTION WAS A TYPE IV ENDOLEAK. IN ADDITION, THE ENDOLEAK SEEN AT EACH JUNCTION WAS OBSERVED AFTER THE PATIENT'S ABDOMEN HAD BEEN OPENED. NO EVIDENCE OF STENT GRAFT SEPARATION OR MINIMAL OVERLAP WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823045 ENDURANT II ILIAC STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ETLW1613C124E 00643169467590

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| R