BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 2960916 · Received February 11, 2013

    Report

    Report Number
    2024601-2013-00044
    Event Type
    Death
    Date Received
    February 11, 2013
    Date of Event
    March 15, 2011
    Report Date
    January 14, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACCESS PORT CONNECTOR ASSOCIATED WITH THIS REPORT WAS NOT RETURNED WITH THE LAP-BAND SYSTEM BY THE REPORTER. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEATH, CARDIOPULMONARY ARREST, FISTULA, EROSION, HEMORRHAGE, INFECTION, INFLAMMATION, ABDOMINAL PAIN, ULCER, VOMIT, MELENA, MALAISE AND TACHYCARDIA ARE SURGICAL PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE PLASTIC SURGERY THAT OCCURRED IN (B)(6) 2012, ALTHOUGH THE OPERATIVE REPORT HAS BEEN REQUESTED. NO AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    REPORTED BY HEALTH PROFESSIONAL AS - A TEENAGE PT WHO HAD AN ALLERGAN GASTRIC BANDING ARRIVED AT THE EMERGENCY OF [FACILITY] BECAUSE OF AN INTERNAL HEMORRHAGE. THE HEMORRHAGE WAS AT THE BANDING CONTACT AND THE STOMACH, WHEN THE PHYSICIAN OF THE CLINIC REMOVED THE BANDING, IT APPEARS THAT THERE WAS A FISTULA AT THE AORTA LEVEL. THE VASCULAR SURGEONS WERE CALLED IN EMERGENCY TO "CLAMP" THE AORTA (CLAMP = INTERRUPT THE BLOOD CIRCULATION DURING A SURGICAL OPERATION). THE PT DID TWO CARDIAC STOPS ON THE TABLE AND THE TEAM WERE NOT SUCCESSFUL IN REVIVING [THE PT] AT THE SECOND STOP. [THE PT] WAS PERFECTLY FOLLOWED BY THE "IMPLANT FACILITY] TEAM SINCE THE IMPLANTATION. THE DEVICE SHOULD HAVE BEEN REMOVED THIS YEAR. ADDITIONAL EXAMS AFTER DEATH WILL BE PERFORMED TO UNDERSTAND WHAT HAPPENED. HYPOTHESIS: THE GASTRIC BANDING IN DIRECT CONTACT WITH AORTA BEHIND THE STOMACH CONDUCTED TO THE ULCERATION OF THE AORTIC WALL AND DERIVED THIS HEMORRHAGE. FOLLOW-UP FINDINGS: PT WAS SEEN 21 MONTHS PRIOR TO DEATH "FOR EPIGASTRALGIES: HELICOBACTER PYLORI GASTRITIS. NO ULCERATIONS. NO MIGRATION OF THE GASTRIC BANDING. DEVICE TOTALLY UNCLENCHED. TREATMENT OF THE GASTRITIS AND ERADICATION OF THE HELICOBACTER. COMPLETE DISAPPEARANCE OF THE SYMPTOM. CONTINUE TO LOSE WEIGHT UNTIL - 100% OF THE WEIGHT EXCESS. ABDOMINAL PLASTIC SURGERY ON [THREE MONTHS PRIOR TO DEATH]. SEVENTY-FOUR KG STABILIZED. SEEN [ONE MONTH LATER]: PERFECT." THE PT PRESENTATION AT [EMERGENCY FACILITY] ON [DAY] BECAUSE OF HEMATEMESIS. NO DEGLOBULISATION. CONSERVED HEMODYNAMIC. NEW MELENA AND HYPOTENSION. FIBROSCOPY IN EMERGENCY = GASTRIC ULCERATION BY THE DEVICE AND INTRA GASTRIC CLOTS. THE DEVICE WAS SCHEDULED FOR EXPLANTATION FOR "DECISION TO EXPLANT BECAUSE OF A PROBABLE HAEMORRHAGE ON ULCERATION ON DEVICE MIGRATION." THE EXPLANATION ON HOW THE AORTA IS NOT CLOSE TO THE STOMACH, SO HOW DID THE BAND GET NEXT TO THE AORTA, WAS ANSWERED AS, "DUE TO THE IMPORTANT LOSS OF WEIGHT AND THE TALLER POSITION OF THE GASTRIC BANDING, THE DEVICE BECAME IN CONTACT WITH THE ANTERIOR FACE OF THE AORTA, WHERE SHE PASSED BETWEEN DIAPHRAGM PILARS." NO AUTOPSY WAS PERFORMED. INVESTIGATION IN PROGRESS. EXPLANT OPERATIVE REPORT RECEIVED AND PROVIDED TO MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60157 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 1719064

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death