BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2831325 · Received November 5, 2012

    Report

    Report Number
    2024601-2012-01188
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    April 28, 2006
    Report Date
    December 14, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. BASED UPON THE MODEL NUMBER PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. DYSPHAGIA, VOMIT, REFLUX, IRRITATION/INFLAMMATION, AND HERNIA ARE SURGICAL /PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: ¿DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING.¿ DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF DYSPHAGIA, GASTRITIS, REFLUX AND INADEQUATE WEIGHT LOSS AS FOLLOWS: "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES." DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF VOMIT AND INADEQUATE WEIGHT LOSS AS FOLLOWS: "NAUSEA AND VOMITING MAY ALSO BE SYMPTOMS OF STOMA OBSTRUCTION OR BAND/STOMACH SLIPPAGE. FREQUENT, SEVERE VOMITING CAN RESULT IN POUCH DILATATION, STOMACH SLIPPAGE OR ESOPHAGEAL DILATATION." DEFLATION OF THE BAND IS IMMEDIATELY INDICATED IN ALL OF THESE SITUATIONS. DEFLATION OF THE BAND MAY ALLEVIATE EXCESSIVELY RAPID WEIGHT LOSS AND NAUSEA AND VOMITING, OR RE-OPERATION TO REPOSITION OR REMOVE THE DEVICE MAY BE REQUIRED." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF HERNIA AS FOLLOWS:"THERE WERE ADDITIONAL OCCURRENCES OF THESE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ESOPHAGITIS, GASTRITIS, HIATAL HERNIA, PANCREATITIS, ABDOMINAL PAIN, HERNIA, INCISIONAL INFECTION, INFECTION, REDUNDANT SKIN, DEHYDRATION, GI PERFORATION, DIARRHEA, ABNORMAL STOOLS, CONSTIPATION, FLATULENCE, DYSPEPSIA, ERUCTATION, CARDIOSPASM, HEMATEMESIS, ASTHENIA, FEVER, CHEST PAIN, INCISION PAIN, CONTACT DERMATITIS, ABNORMAL HEALING, EDEMA, PARESTHESIA, DYSMENORRHEA, HYPOCHROMIC ANEMIA, BAND LEAK, CHOLECYSTITIS, ESOPHAGEAL DYSMOTILITY, ESOPHAGEAL ULCER, ESOPHAGITIS, PORT DISPLACEMENT, PORT SITE PAIN, SPLEEN INJURY AND WOUND INFECTION."

    Description of Event or Problem · 1

    PT REPORTED APPROXIMATELY FIVE YRS AFTER PLACEMENT OF THE LAP-BAND SYSTEM AND EXPERIENCING MULTIPLE EVENTS OF DYSPHAGIA, VOMITING, ALONG WITH INADEQUATE WEIGHT LOSS THE DEVICE WAS EXPLANTED WITHOUT REPLACEMENT. PREVIOUSLY THE PHYSICIAN PERFORMED MULTIPLE FILL ADJUSTMENTS BUT THEN ELECTED TO FULLY DEFLATE THE BAND, HOWEVER DYSPHAGIA AND VOMITING CONTINUED. DIAGNOSTIC TESTING PERFORMED AND DIAGNOSE OF HIATAL HERNIA, ESOPHAGITIS, AND "MILD GASTROESOPHAGEAL REFLUX. THE PHYSICIAN ALSO SUSPECTED A "LEAK WITHIN THE BAND/PORT SYSTEM BECAUSE FLUID THAT WAS INJECTED INTO THE PORT COULD NOT BE ASPIRATED". DURING EXPLANT SURGERY THE PHYSICIAN NOTED UPON PORT REMOVAL FROM THE ABDOMINAL WALL THAT THE PORT "WAS SEEN TO BE COMPLETELY SEVERED FROM THE TUBING [...] RIGHT THROUGH THAT FLANGE APPROXIMATELY A CENTIMETER OR SO OUT FROM THE PORT ITSELF." A SECOND TUBING BREAK WAS FOUND AFTER TUBING WAS PULLED INTO THE ABDOMINAL CAVITY AND THE SEVERED TUBING "DID NOT MATCH THE TRANSECTED END." A "THIRD INTERVENING SEGMENT" WAS LOCALIZED AND DISSECTED OUT OF THE ABDOMINAL WALL. THE PT LEFT THE OPERATING ROOM IN SATISFACTORY CONDITION. POST-EXPLANT SURGERY, PHYSICIAN DISCUSSED OPERATIVE FINDINGS WITH THE PT AND "STRESSED THAT [PT'S] SYMPTOMS COULD NOT BE EXPLAINED BY ANY SORT OF MALFUNCTION OF THE BAND SYSTEM," AND FELT THAT THE FRACTURE WOULD HAVE "CAUSED A LESSENING OF [PT'S] DYSPHAGIA SYMPTOMS, NOT AN AGGRAVATION THEREOF." THE PHYSICIAN STATED THE BELIEF THAT PT "SIMPLY COULD NOT TOLERATE THE SENSATION OF THE BAND AROUND THE UPPER PORTION OF THE STOMACH. THE BAND ITSELF LOOKED NORMAL AS DID ITS POSITION AROUND THE TOP OF THE STOMACH WHICH ALSO LOOKED APPROPRIATE." THREE MONTHS LATER THE PT ELECTED TO UNDERGO ROUX-EN-Y GASTRIC BYPASS SURGERY. APPROXIMATELY ONE YR LATER THE PT WAS "RUSHED TO THE ER VOMITING UP BLOOD." AND AN ENDOSCOPY WAS PERFORMED WHICH FOUND AN "ULCER RUPTURED AND BROKE A BLOOD VESSEL IN [PT'S] STOMACH." THE PT REPORTS FOLLOWING LAP-BAND EXPLANT SURGERY, PT HAS SUFFERED FROM "SEVERE STOMACH ULCERS" AS A RESULT OF "PART OF THE TUBING [...] EMBEDDED INTO A PORTION OF [PT'S] STOMACH TISSUE. [PHYSICIAN] EXPLAINED IT WAS DIFFICULT FOR [PHYSICIAN] TO REMOVE IT HENCE WHERE THE ULCER DEVELOPED." EVENTS REGARDING THE REPORTS OF "STOMACH ULCERS" HAVE NOT BEEN CONFIRMED BY PT'S PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention CITALOPRAM| PROTONIX| ADIPEX-P| HYCODAN| CELEBREX| CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE| LORTAB| TYLENOL| LIBRAX| LIPOTROPIC AND B12 INJECTIONS| NAPROXEN SODIUM| BILATERAL ORTHOVISC INJECTIONS| EPIDURAL BLOCKS| ALLEGRA| PHENTEMINE| SIMVASTATIN| PRILOSEC| NON-STEROIDAL ANTI-INFLAMMATORY DRUGS| KLONOPIN