BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORBERA INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 6187493 · Received December 19, 2016

    Report

    Report Number
    3006722112-2016-00385
    Event Type
    Injury
    Date Received
    December 19, 2016
    Report Date
    March 10, 2017
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    UDI-DI
    10811955020619
    PMA / PMN Number
    P140008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER OF THE EVENTS WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, AND TO INDICATE PRODUCT SERIAL NUMBER. TO DATE, NEITHER THE DEVICE NOR ANY FURTHER DEVICE INFORMATION HAS BEEN RECEIVED BY APOLLO. DEVICE LABELING ADDRESS THE REPORTED EVENTS AS FOLLOWS: 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. 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. 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.

    Additional Manufacturer Narrative · 1

    SUPPLEMENT #1: MEDWATCH SENT TO FDA ON 04/07/2017. DEVICE LABELING ADDRESSES THE REPORTED EVENT AS FOLLOWS: ADVERSE EVENTS: POSSIBLE COMPLICATIONS POSSIBLE COMPLICATIONS OF THE USE OF ORBERA INCLUDE: ABDOMINAL OR BACK PAIN, EITHER STEADY OR CYCLIC. BLOCKAGE OF FOOD ENTERING INTO THE STOMACH. BACTERIAL GROWTH IN THE FLUID WHICH FILLS THE BALLOON. RAPID RELEASE OF THIS FLUID INTO THE INTESTINE COULD CAUSE INFECTION, FEVER, CRAMPS AND DIARRHEA. POSSIBLE COMPLICATIONS OF ROUTINE ENDOSCOPY AND SEDATION: POTENTIAL RISKS ASSOCIATED WITH UPPER ENDOSCOPIC PROCEDURES INCLUDE, BUT ARE NOT LIMITED TO: ABDOMINAL CRAMPING AND DISCOMFORT FROM THE AIR USED TO DISTEND THE STOMACH, SORE OR IRRITATED THROAT, BLEEDING, INFECTION, TEARING OF THE ESOPHAGUS OR STOMACH, AND ASPIRATION PNEUMONIA. THE RISK INCREASES IF ADDITIONAL PROCEDURES ARE PERFORMED. (B)(6) STUDY: THE EVENT OF DEHYDRATION WAS REPORTED IN THE (B)(6) CLINICAL STUDY AND WAS EXPERIENCED BY 1.3% OF THE PARTICIPANTS.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT HAD THE ORBERA INTRAGASTRIC BALLOON PLACED, "THE PATIENT WAS BLOATED AND HADN'T BEEN ABLE TO SLEEP". THE PHYSICIAN PERFORMED AN X-RAY AND DECIDED THE BALLOON NEEDED TO COME OUT NOW. PHYSICIAN CONFIRMED, "PATIENT HAVING PROFOUND GASTROPARESIS AND WAS CONSTANTLY VOMITING AND REGURGITATING". THE BALLOON WAS REMOVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: A PATIENT WITH THE ORVERA INTRAGASTRIC BALLOON ADDITIONALLY REPORTED "POST-SURGICAL DISCOMFORT. IMMEDIATELY FOLLOWING IMPLANT SURGERY, BEGAN TO FEEL EXTREMELY BLOATED. THE BLOATING HAD CULMINATED INTO VOMITING, SEVERE ABDOMINAL PAINS, AND SEVERE DISCOMFORT. THE PAIN WAS BECOMING UNBEARABLE. WAS GIVEN MEDICATIONS AND IV TREATMENTS FOR DEHYDRATION. THE DEVICE BLOCKED MOST IF NOT ALL FOOD FROM PASSING THROUGH STOMACH. CONTRACTED PNEUMONIA IMMEDIATELY POST REMOVAL SURGERY AS A RESULT OF THE ASPIRATION STOMACH CONTENTS DURING THE FINAL SURGERY. AFFECTED PHYSICAL AND EMOTIONAL WELL-BEING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837242 ORBERA INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. B-4800 RWAP0000 10811955020619

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention