BEUDAMED
    FDA Adverse Event Death Summary report: N

    ORBERA® INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 12247856 · Received July 29, 2021

    Report

    Report Number
    3006722112-2021-00065
    Event Type
    Death
    Date Received
    July 29, 2021
    Report Date
    November 8, 2021
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P140008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENT #01 MEDWATCH SUBMITTED TO THE FDA ON10/NOV/2021. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. DEVICE EVALUATION SUMMARY: MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION BUT WERE NOT PROVIDED. ASSESSMENT OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT POSSIBLE, AND IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THIS EVENT. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    INSUFFICIENT INFORMATION IS AVAILABLE AT THIS TIME. WE ARE COMPLETING OUR DUE DILIGENCE TO GATHER AS MUCH INFORMATION AS POSSIBLE REGARDING THIS EVENT. THE ACTUALLY DATE OF THE DEATH HAS NOT BEN REPORTED TO APOLLO. THAT THE REASON FOR THE (B)(6) 2021. IF THE DEVICE INFORMATION BECOMES AVAILABLE, A DEVICE HISTORY RECORD (DHR) REVIEW WILL ALSO BE INCLUDED. A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: THE CURRENT ORBERA¿ INTRAGASTRIC BALLOON SYSTEM DIRECTIONS FOR USE (DFU) ADDRESSES THE KNOWN AND ANTICIPATED POTENTIAL EVENTS OF "DEATH" AS FOLLOWS: WARNINGS AND PRECAUTIONS: THE RISK OF BALLOON DEFLATION AND INTESTINAL OBSTRUCTION (AND THEREFORE POSSIBLE DEATH RELATED TO INTESTINAL OBSTRUCTION) IS SIGNIFICANTLY HIGHER WHEN BALLOONS ARE LEFT IN PLACE LONGER THAN 6 MONTHS OR USED AT LARGER VOLUMES (GREATER THAN 700 CC). THE PHYSIOLOGICAL RESPONSE OF THE PATIENT TO THE PRESENCE OF ORBERA¿ 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. PATIENTS NEED TO BE EVALUATED AND THE DEVICE REMOVED AT OR WITHIN 6 MONTHS OF PLACEMENT. CLINICAL DATA DOES NOT EXIST TO SUPPORT USE OF AN INDIVIDUAL ORBERA¿ BEYOND 6 MONTHS. INJURY TO THE DIGESTIVE TRACT DURING PLACEMENT OF THE BALLOON IN AN IMPROPER LOCATION SUCH AS IN THE ESOPHAGUS OR DUODENUM. THIS COULD CAUSE BLEEDING AND PERFORATION, WHICH COULD REQUIRE A SURGICAL OR ENDOSCOPIC CORRECTION FOR CONTROL. INJURY TO THE LINING OF THE DIGESTIVE TRACT AS A RESULT OF DIRECT CONTACT WITH THE ENDOSCOPE, 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. POTENTIAL RISKS ASSOCIATED WITH UPPER ENDOSCOPIC PROCEDURES INCLUDE, BUT ARE NOT LIMITED TO: ABDOMINAL CRAMPING AND DISCOMFORT IF AIR USED TO DISTEND THE STOMACH, SORE OR IRRITATED THROAT, BLEEDING, INFECTION, TEARING OF THE ESOPHAGUS OR STOMACH THAT COULD LEAD TO PERFORATION, AND ASPIRATION PNEUMONIA. THE RISK INCREASES IF ADDITIONAL PROCEDURES ARE PERFORMED. PRECAUTIONS: ANTIEMETICS, ANTISPASMODIC, AND ANTICHOLINERGIC DRUGS MAY BE PRESCRIBED TO LESSEN THE EARLY PLACEMENT SYMPTOMS SUCH AS NAUSEA, VOMITING, AND ABDOMINAL PAIN. PATIENTS WILL NEED TO IMMEDIATELY CONTACT THEIR PHYSICIAN FOR ANY SEVERE OR UNUSUAL SYMPTOMS. PLACEMENT OF THE BALLOON WITHIN THE STOMACH PRODUCES AN EXPECTED AND PREDICTABLE REACTION CHARACTERIZED MOST COMMONLY BY A FEELING OF HEAVINESS IN THE ABDOMEN, NAUSEA AND VOMITING, GASTROESOPHAGEAL REFLUX, BELCHING, ESOPHAGITIS, HEARTBURN, DIARRHEA AND, AT TIMES, ABDOMINAL, BACK OR EPIGASTRIC PAIN AND CRAMPING. FOOD DIGESTION MAY BE SLOWED DURING THIS ADJUSTMENT PERIOD. THESE SYMPTOMS CAN BE TREATED WITH ANTIEMETIC, ANTISPASMODIC, AND ANTICHOLINERGIC MEDICATIONS. TYPICALLY THE STOMACH ACCLIMATES TO THE PRESENCE OF THE DEVICE WITHIN THE FIRST 2 WEEKS. IN ORDER TO PREVENT OR AMELIORATE THE SYMPTOMS MOST FREQUENTLY EXPERIENCED DURING THE ADJUSTMENT PERIOD, IT IS RECOMMENDED THAT THE PHYSICIAN USE PROTON PUMP INHIBITORS (PPIS), ANTIEMETICS, ANTISPASMODICS, AND ANTICHOLINERGIC MEDICATIONS PROPHYLACTICALLY (BEFORE ORBERA¿ PLACEMENT). PATIENTS SHOULD BE ADVISED TO IMMEDIATELY CONTACT THEIR PHYSICIAN FOR ANY UNUSUALLY SEVERE OR WORSENING SYMPTOMS. ADVERSE EVENTS: IT IS IMPORTANT TO DISCUSS ALL POSSIBLE COMPLICATIONS AND ADVERSE EVENTS WITH YOUR PATIENT. COMPLICATIONS THAT MAY RESULT FROM THE USE OF THIS PRODUCT INCLUDE THE RISKS ASSOCIATED WITH THE MEDICATIONS AND METHODS UTILIZED IN THE ENDOSCOPIC PROCEDURE, THE RISKS ASSOCIATED WITH ANY ENDOSCOPIC PROCEDURE, THE RISKS ASSOCIATED WITH THE ORBERA INTRAGASTRIC BALLOON SPECIFICALLY, AND THE RISKS ASSOCIATED WITH THE PATIENT'S DEGREE OF INTOLERANCE TO A FOREIGN OBJECT PLACED IN THE STOMACH. POSSIBLE COMPLICATIONS - POSSIBLE COMPLICATIONS OF THE USE OF ORBERA¿ INCLUDE: GASTRIC DISCOMFORT, FEELINGS OF NAUSEA AND VOMITING FOLLOWING BALLOON PLACEMENT AS THE DIGESTIVE SYSTEM ADJUSTS TO THE PRESENCE OF THE BALLOON. CONTINUING NAUSEA AND VOMITING. THIS COULD RESULT FROM DIRECT IRRITATION OF THE LINING OF THE STOMACH OR AS A RESULT OF THE BALLOON BLOCKING THE OUTLET OF THE STOMACH. IT IS EVEN THEORETICALLY POSSIBLE THAT THE BALLOON COULD PREVENT VOMITING (NOT NAUSEA OR RETCHING) BY BLOCKING THE INLET TO THE STOMACH FROM THE ESOPHAGUS. DEATH DUE TO COMPLICATIONS RELATED TO INTESTINAL OBSTRUCTION IS POSSIBLE. COMPLICATIONS OF ROUTINE ENDOSCOPY INCLUDE: ADVERSE REACTION TO SEDATION OR LOCAL ANESTHETIC. CARDIAC OR RESPIRATORY ARREST (THESE ARE EXTREMELY RARE AND ARE USUALLY RELATED TO SEVERE UNDERLYING MEDICAL PROBLEMS).

    Description of Event or Problem · 1

    PATIENT DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146035 ORBERA® INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON SYSTEM LTI APOLLO ENDOSURGERY, INC. B-40800

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Death