BEUDAMED
    FDA Adverse Event Death Summary report: N

    ORBERA INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 7067558 · Received November 29, 2017

    Report

    Report Number
    3006722112-2017-00395
    Event Type
    Death
    Date Received
    November 29, 2017
    Date of Event
    September 10, 2017
    Report Date
    November 1, 2017
    Manufacturer
    APOLLO ENDOSURGERY, INC
    Product Code
    LTI
    PMA / PMN Number
    P140008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO THE FDA ON (B)(6) 2017. APOLLO RECEIVED NOTICE THAT THE DEVICE WOULD NOT BE RETURNED. DEVICE LABELING ADDRESSES THE REPORTED EVENT AS FOLLOWS: WARNINGS AND PRECAUTIONS: THE PHYSIOLOGICAL RESPONSE OF THE PATIENT TO THE PRESENCE OF THE ORBERA SYSTEM BALLOON MAY VARY DEPENDING UPON THE PATIENT'S GENERAL CONDITION AND THE LEVEL AND TYPE OF ACTIVITY. THE TYPES AND FREQUENCY OF ADMINISTRATION OF DRUGS OR DIET SUPPLEMENTS AND THE OVERALL DIET OF THE PATIENT MAY ALSO AFFECT THE RESPONSE. EACH PATIENT MUST BE MONITORED CLOSELY DURING THE ENTIRE TERM OF TREATMENT IN ORDER TO DETECT THE DEVELOPMENT OF POSSIBLE COMPLICATIONS. EACH PATIENT SHOULD BE INSTRUCTED REGARDING SYMPTOMS OF DEFLATION, GASTROINTESTINAL OBSTRUCTION, ULCERATION AND OTHER COMPLICATIONS WHICH MIGHT OCCUR, AND SHOULD BE ADVISED TO CONTACT HIS/HER PHYSICIAN IMMEDIATELY UPON THE ONSET OF SUCH SYMPTOMS. COMPLICATIONS - POSSIBLE COMPLICATIONS OF THE USE OF THE ORBERA® SYSTEM INCLUDE: - DEATH DUE TO COMPLICATIONS RELATED TO INTESTINAL OBSTRUCTION IS POSSIBLE. -GASTRIC DISCOMFORT, FEELINGS OF NAUSEA AND VOMITING FOLLOWING BALLOON PLACEMENT AS THE DIGESTIVE SYSTEM ADJUSTS TO THE PRESENCE OF THE BALLOON. -A FEELING OF HEAVINESS IN THE ABDOMEN. -ABDOMINAL OR BACK PAIN, EITHER STEADY OR CYCLIC. -INJURY TO THE LINING OF THE DIGESTIVE TRACT AS A RESULT OF DIRECT CONTACT WITH THE BALLOON, GRASPING FORCEPS, OR AS A RESULT OF INCREASED ACID PRODUCTION BY THE STOMACH. THIS COULD LEAD TO ULCER FORMATION WITH PAIN, BLEEDING OR EVEN PERFORATION. SURGERY COULD BE NECESSARY TO CORRECT THIS CONDITION. COMPLICATIONS OF ROUTINE ENDOSCOPY INCLUDE: -DIGESTIVE TRACT INJURY OR PERFORATION.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH THE ORBERA INTRAGASTRIC BALLOON HAD CONTACTED THEIR PHYSICIAN ONE WEEK POST PLACEMENT NOTING DISCOMFORT WITH UPPER ABDOMINAL PAIN AND A FEELING OF FULLNESS. THE PHYSICIAN ADVISED THE PATIENT TO COME IN FOR AN EVALUATION AND THE VITAL SIGNS AND O2 SATURATION WAS NORMAL. THE PHYSICIAN NOTED THERE WAS SOME EPIGASTRIC TENDERNESS, OTHERWISE THE PATIENT HAD A SOFT ABDOMEN AND GENERAL IMPRESSION WAS THIS WAS TYPICAL SYMPTOMOLOGY SEEN DURING THE FIRST WEEK OF TREATMENT. THE PATIENT SPOKE TO THE PHYSICIAN LATER THAT EVENING NOTING THEY WERE STILL IN PAIN AND THE PHYSICIAN REQUESTED THE PATIENT TO BE SEEN THE FOLLOWING MORNING. THE PATIENT PASSED AWAY THE FOLLOWING MORNING. IT WAS REPORTED THAT THE PATIENT HAD A GASTRIC PERFORATION WITH INTRA-ABDOMINAL HEMORRHAGE AND BLOOD IN THE AIRWAYS. A NECROPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846405 ORBERA INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC B-50000 2908361

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death