BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1458422 · Received August 27, 2009

    Report

    Report Number
    3005992282-2009-00246
    Event Type
    Injury
    Date Received
    August 27, 2009
    Date of Event
    August 2, 2009
    Report Date
    August 5, 2009
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 08/27/2009. INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. CONSULTATION WITH OBTECH MEDICAL CONSULTANT: WHAT I CAN SPECULATE FROM THE DESCRIPTION IS THAT IT'S HIGHLY LIKELY THAT THE PT PRESENTED WITH "BAND SLIPPAGE" SYMPTOMS. ALTHOUGH THIS CONDITION IS CALLED "BAND SLIPPAGE", IN FACT IT MEANS THAT THE STOMACH (NOT THE BAND) SLIPPED THROUGH THE BAND UPWARDS. THIS CONDITION IS NOT RARE IN GASTRIC BANDED PTS, AND IS REPORTED IN APPROX. 1-3% OF ALL PTS WITH GASTRIC BAND IN LONG-TERM F/U. "BAND SLIPPAGE" IS NOT, IN VAST MAJORITY OF CASES, A LIFE THREATENING CONDITION. HOWEVER IN A SMALL PERCENTAGE OF PTS THE SLIPPAGE CAN BE SERIOUS. THIS APPLIES TO CASES WHEN LARGE PORTION OF THE STOMACH IS SLIPPED THROUGH (BEHIND) THE BAND, THUS BLOOD SUPPLY TO THE STOMACH MAY BE COMPROMISED. IN A VIEW OF THIS WELL KNOWN POTENTIAL THREAT TO STOMACH BLOOD SUPPLY, IT'S USUALLY ADVISED TO PERFORM URGENT UPPER-GI ENDOSCOPY IN PTS PRESENTING WITH EPIGASTRIA PAIN, USUALLY ASSOCIATED WITH SEVERE, REPEATED AND LASTING VOMITING. UPPER-GI ENDOSCOPY CAN REVEAL COMPROMISED BLOOD SUPPLY TO THE STOMACH AND MAY INDICATE NEED FOR AN EARLY INTERVENTION (REOPERATION-BAND REMOVAL), ESPECIALLY IN CASES WHEN BAND DEFLATION DOES NOT RESTORE ADEQUATE BLOOD SUPPLY TO THE STOMACH. FROM THIS POINT, I WOULD CONCLUDE THAT THIS EVENT IS NOT DIRECTLY RELATED TO THE DEVICE (THE BAND). SUCH CONDITION IS KNOWN AND MAY HAPPEN IN CERTAIN PERCENTAGE OF PTS. USUALLY, IF TREATED ADEQUATELY AND SOON (DEPENDS AS WELL ON THE LENGTH OF TIME ELAPSED BEFORE THE PT SEEKS MEDICAL ADVICE) IT DOES NOT LEAD TO STOMACH NECROSIS. SO, IN SUCH CASES THE TREATMENT IS PRETTY STRAIGHT FORWARD - BAND REMOVAL. SUCH PROCEDURE (EARLY REOPERATION) IS USUALLY ENOUGH TO RESTORE NORMAL BLOOD SUPPLY TO THE STOMACH AND LEADS TO FULL RESTORATION OF NORMAL ANATOMY. IF THE SURGICAL INTERVENTION IS, HOWEVER, DELAYED THEN THE SITUATION MAY LEAD TO STOMACH NECROSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED A YEAR POST OP A GASTRIC BAND PROCEDURE, IN 2009, THE PT CAME INTO ER WITH EPIGASTRIC PAIN. THE BARIATRIC SURGEON ON CALL REMOVED ALL THE FLUID FROM THE BAND AND THE PT FELT BETTER AND WAS SENT HOME. THE NEXT EVENING, THE PT RETURNED TO THE ER WITH SEVERE EPIGASTRIC PAIN. THE SURGEON ON CALL DIAGNOSED NECROTIC STOMACH. ON THE MORNING OF THE FOLLOWING DAY, THE SURGEON PERFORMED A SUBTOTAL GASTRECTOMY OF ALL THE NECROTIC STOMACH, APPROXIMATELY 80%, DISTAL TO THE BAND. THE BAND, NOT THE PORT, WAS ALSO REMOVED AT THIS TIME. AFTER THE SUBTOTAL GASTRECTOMY, THE PT WAS LEFT WITH A SMALL POUCH OF PROXIMAL STOMACH. TWO DAYS LATER, THE ORIGINAL REALIZE BAND SURGEON REOPERATED ON THE PT AND PERFORMED A GASTROJEJUNOSTOMY AND COMPLETED A ROUX EN Y, AND REMOVED THE PORT. THERE WAS NO REPORTED PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE ADJ GASTRIC BAND STR LTI OBTECH MEDICAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention