BEUDAMED
    FDA Adverse Event Death Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 1917308 · Received December 8, 2010

    Report

    Report Number
    3005099803-2010-05010
    Event Type
    Death
    Date Received
    December 8, 2010
    Date of Event
    October 22, 2010
    Report Date
    November 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: THOUGH THE PATIENT'S EXACT AGE IS UNKNOWN, SHE IS REPORTED TO BE IN HER 50S. THOUGH THE EXACT DATE OF IMPLANTATION IS UNKNOWN, THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED IN (B)(6) 2010. THOUGH THE LOT# OF THE DEVICE IS UNKNOWN, THE COMPLAINANT INDICATED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRATION DATE. THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOLLOWING A CYSTOCELE REPAIR WITH SACROSPINOUS LIGAMENT FIXATION PROCEDURE PERFORMED USING A PINNACLE ANTERIOR/APICAL PFR KIT IN (B)(6) 2010 (EXACT PROCEDURE DATE UNKNOWN), THE PATIENT PRESENTED WITH A 20 CENTIMETER HEMATOMA AND "POSSIBLE" EROSION IN THE BLADDER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT GENERAL ANESTHESIA (SPECIFIC TYPE UNKNOWN) WAS USED DURING THE DEVICE IMPLANTATION PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT GENERAL ANESTHESIA (SPECIFIC TYPE UNKNOWN) WAS USED DURING THE DEVICE IMPLANTATION PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ON (B)(6) 2010, THE PATIENT HAD A PINNACLE ANTERIOR/APICAL PELVIC FLOOR REPAIR KIT AND MINIARC SLING (NOT A BOSTON SCIENTIFIC DEVICE) PLACEMENT PROCEDURE. A VERTICAL INCISION WAS USED TO PLACE THE PINNACLE MESH, AND THE ENTIRE PROCEDURE LASTED 37 MINUTES. ACCORDING TO THE IMPLANTING PHYSICIAN, THE PATIENT HAD CHRONIC HYPERTENSION AND DIABETES, BUT HAD RECENTLY RECEIVED CLEARANCE FROM HER INTERNIST AND CARDIOLOGIST FOR THIS PROCEDURE. THE PATIENT TOOK AN ANNUAL STRESS TEST, BUT IT IS UNKNOWN WHETHER SHE HAD A CARDIAC DIAGNOSIS. REPORTEDLY, THE PATIENT "WENT STRAIGHT FROM THE OPERATING ROOM TO THE INTENSIVE CARE UNIT AND NEVER LEFT." IMMEDIATELY FOLLOWING THE PROCEDURE, THE PATIENT WAS REINTUBATED AND PUT ON A VENTILATOR. THE PATIENT DEVELOPED PULMONARY EDEMA AND ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS). SUBSEQUENTLY, THE PATIENT PRESENTED WITH DISSEMINATED INTRAVASCULAR COAGULOPATHY (DIC), WHICH THE PHYSICIAN STATED CAN RESULT FROM ARDS. THE DIC AFFECTED THE PATIENT'S KIDNEYS, AND SHE UNDERWENT KIDNEY DIALYSIS. THE PATIENT PRESENTED WITH BLOOD IN HER URINE SEVEN DAYS POST-PROCEDURE, AND AN ULTRASOUND WAS PERFORMED, WHICH "REVEALED NOTHING." A CYSTOSCOPY WAS PERFORMED EIGHT DAYS POST-PROCEDURE, TO DIAGNOSE ABDOMINAL WALL DISTENSION. THE BLADDER WAS FOUND TO BE "NORMAL;" THE DISTENSION WAS ATTRIBUTED TO A "LARGE" ABDOMINAL HEMATOMA. THE PHYSICIAN OPINED THAT THE HEMATOMA WAS CAUSED BY LACERATION OF THE INFERIOR GASTRIC ARTERY, CAUSED BY THE DIALYSIS CATHETER. MULTIPLE ATTEMPTS WERE PERFORMED TO TRY AND DRAIN THE HEMATOMA USING AN ABDOMINAL CATHETER. THE ABDOMINAL HEMATOMA REPORTEDLY "PRESSED, ON THE PATIENT'S BLADDER, PUTTING PRESSURE ON HER FOLEY CATHETER BULB, WHICH IN TURN PRESSED AGAINST THE INTERIOR BLADDER WALL AND CAUSED TISSUE NECROSIS. THE PHYSICIAN STATED THERE WAS NO PINNACLE MESH EROSION INTO THE BLADDER. THE PHYSICIAN REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2011. THE PHYSICIAN ATTRIBUTES THE DEATH TO COMPLICATIONS RESULTING FROM THE ANESTHESIA USED DURING THE PLACEMENT PROCEDURE, WHICH LED TO MULTIPLE ORGAN FAILURE, PRECIPITATED BY LUNG FAILURE. THE PHYSICIAN EMPHASIZED THAT HE BELIEVES NEITHER THE PINNACLE DEVICE NOR THE PINNACLE PLACEMENT HAD ANY RELATION TO THE PATIENT'S DEATH, AND THERE WAS NO DEVICE MALFUNCTION. THE PHYSICIAN STATED THAT HE DOES NOT KNOW IF AN AUTOPSY WAS PERFORMED; "THE BODY WAS TRANSFERRED TO (B)(6) HOSPITAL." HE INDICATED THAT HE WILL NOTIFY US IF HE LEARNS THAT AN AUTOPSY REPORT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317050

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death| H| O MINIARC SLING (NOT A BSC PRODUCT)