BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE DRYSEAL SHEATH

    MDR report key: 2430289 · Received January 23, 2012

    Report

    Report Number
    2017233-2012-00038
    Event Type
    Death
    Date Received
    January 23, 2012
    Date of Event
    December 27, 2011
    Report Date
    December 27, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    DYB
    PMA / PMN Number
    K093791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE GORE DRYSEAL SHEATH INSTRUCTIONS FOR USE, DO NOT ATTEMPT SHEATH ADVANCEMENT OR WITHDRAWAL WITHOUT GUIDEWIRE AND DILATOR IN PLACE. MAJOR BLEEDING, VESSEL DAMAGE, OR SERIOUS INJURY TO THE PT, INCLUDING DEATH, MAY RESULT. ACCORDING TO THE GORE DRYSEAL SHEATH INSTRUCTIONS FOR USE, THE OUTSIDE DIAMETER OF A 22 FR DRYSEAL SHEATH IS 8.3MM.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT WAS BROUGHT TO THE OPERATING ROOM FOR A REPAIR OF A HEMODYNAMICALLY STABLE DESCENDING THORACIC AORTIC TRANSECTION INJURY WHICH SHE SUSTAINED 3 DAYS PRIOR DURING A MOTOR VEHICLE ACCIDENT. THE PHYSICIAN CHOSE TO HAVE BILATERAL FEMORAL ACCESS VIA ULTRASOUND GUIDED PERCUTANEOUS APPROACH WITH A 5FR SHEATH ON THE LEFT AND A 22 FR SHEATH ON THE RIGHT. THE SDV2228 WAS PLACED PERCUTANEOUSLY AFTER THE ARTERIAL ENTRY SITE WAS PRECLOSED WITH TWO ABBOTT VASCULAR PERCLOSE DEVICES WHICH WERE PLACED WITHOUT INCIDENT. THE SDV2228 WAS PLACED INTO THE INFRARENAL AORTA OVER A COOK LUNDERQUIST WIRE WITHOUT INCIDENT IN THE INTENDED LOCATION WITH A SUCCESSFUL ANGIOGRAPHIC RESULT PER THE PHYSICIAN. THE SDV2228 WAS REMOVED OVER THE COOK LUNDERQUIST GUIDEWIRE WITHOUT THE DILATOR BEING RE-INTRODUCED (7210 R); THIS STEP TOOK SIGNIFICANT FORCE TO WITHDRAW THE SHEATH AND WHEN REMOVED THERE WAS EVIDENCE OF ILIAC TISSUE REMAINING ON THE SHEATH. THE PT'S BLOOD PRESSURE DECREASED BUT SHE REMAINED STABLE. A SHEATH WAS RE-INTRODUCED INTO THE RIGHT GROIN OVER THE WIRE AND A RETROGRADE ANGIOGRAM WAS PERFORMED THROUGH THE SHEATH. THERE WAS ANGIOGRAPHIC EVIDENCE OF AN ILIAC DISRUPTION IN THE RIGHT EXTERNAL ILIAC AND THE COMMON ILIAC APPEARED TO BE INTACT. THE PHYSICIAN IMPLANTED A VBH091502 STENT WITHOUT INCIDENT AND THE PT'S BLOOD PRESSURE STABILIZED. THE PHYSICIAN CHOSE TO CUT-DOWN ON THE RIGHT FEMORAL ARTERY TO PERFORM A DIRECT ARTERIOTOMY CLOSURE; A 9 MM BALLOON WAS PLACED AND INFLATED IN THE VBH091502 FOR PROXIMAL CONTROL WHILE HE PERFORMED THE CUT-DOWN. THE PHYSICIAN STATED THAT THE ENTIRE FEMORAL ARTERY AND THE DISTAL EXTERNAL ARTERY WERE "GONE" UPON HIS EXPOSURE AND ATTEMPTED TO SEW A CONDUIT FROM THE DISTAL END OF THE VB H091502 TO THE DISTAL COMMON FEMORAL ARTERY. WHILE PREPARING TO DO THIS THE PHYSICIAN STATED THE VBH091502 WAS "SLIDING OUT OF THE ILIAC" AND THE PT'S BLOOD PRESSURE BEGAN TO BECOME UNSTABLE. THE PHYSICIAN PLACE A COOK CODA 32MM AORTIC OCCLUSION BALLOON FOR PROXIMAL AORTIC CONTROL. THE PHYSICIAN FELT HE HAD EXHAUSTED ALL OF THE ENDOVASCULAR OPTIONS AND CHOSE TO CONVERT TO AN OPEN AORTIC REPAIR. UPON HIS DISSECTION TO EXPOSE THE PT'S AORTA AND ILIACS IN PREPARATION OF HIS OPEN REPAIR THE PHYSICIAN STATED HE "GOT INTO SOME VENOUS BLEEDING" IN THE AREA OF THE RIGHT ILIAC SYSTEM AND WAS UNABLE TO CONTROL THE BLEEDING. HE STATED HE FELT HE HAD EXHAUSTED HIS OPTIONS TO CONTROL THE BLEEDING AND CHOSE TO CLOSE AND PACK THE WOUND, CLOSE THE PT UNTIL THE PT EXPIRED. ON (B)(6) 2011 THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE DRYSEAL SHEATH DYB/INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES,INC WLG401

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death IMITREX 50 MG| LYRICA 150 MG| DETROLLA 4MG| FROVA 2.5MG| VIT B| ZOCOR 10 MG| ACIPHEX 20 MG| TERABRAN-M 27-0.4MG| PATANOL| TRICOR 145 MG| ACEBUTOLOL 400MB| VICODIN 5-500MG| ALPRAZOLAM 1 MG| AMLODIPINE 10MG| GLUCOSAMINE CHONDROITIN| CELECOXIB 100MG