BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBERA365¿ INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 16283419 · Received February 2, 2023

    Report

    Report Number
    3006722112-2023-00005
    Event Type
    Malfunction
    Date Received
    February 2, 2023
    Date of Event
    November 8, 2022
    Report Date
    January 17, 2023
    Manufacturer
    APOLLO ENDOSURGERY, INC
    Product Code
    LTI
    PMA / PMN Number
    P140008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MEDWATCH SUBMITTED TO THE FDA ON (B)(6) 2023. A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: THE CURRENT ORBERA365¿ INTRAGASTRIC BALLOON SYSTEM DIRECTIONS FOR USE (DFU) ADDRESSES THE KNOWN AND ANTICIPATED POTENTIAL EVENTS OF NEUROLOGICAL DISORDER AND EARLY REMOVAL. WARNINGS EACH PATIENT MUST BE MONITORED CLOSELY DURING THE ENTIRE TERM OF TREATMENT IN ORDER TO DETECT THE DEVELOPMENT OF POSSIBLE ADVERSE EVENTS. EACH PATIENT SHOULD BE INSTRUCTED REGARDING SYMPTOMS OF DEFLATION, GASTROINTESTINAL OBSTRUCTION, ACUTE PANCREATITIS, IGB INFLATION AFTER PLACEMENT (I.E. SPONTANEOUS HYPERINFLATION), ULCERATION, GASTRIC AND ESOPHAGEAL PERFORATION, AND OTHER ADVERSE EVENTS 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 12 MONTHS OF PLACEMENT. HYPERINFLATION OF THE IGB OFTEN WARRANTS ITS EARLY REMOVAL TO PREVENT SERIOUS COMPLICATIONS SUCH AS GASTRIC OUTLET OBSTRUCTION AND CONTACT ULCERATION. BECAUSE HYPERINFLATION INCREASES THE INTERNAL PRESSURE OF THE IGB (DUE TO ACCUMULATED GAS) AND MAY INCREASE THE FRAGILITY OF THE IGB WALL, THERE IS AN INCREASED RISK OF RUPTURE FOLLOWED BY THE SUDDEN FORCEFUL RELEASE OF GAS AND FLUID CONTENTS WHEN IT IS PUNCTURED OR ENDOSCOPICALLY MANIPULATED. THEREFORE, IT IS SUGGESTED THAT THE PATIENT'S AIRWAY IS PROTECTED WITH ENDOTRACHEAL INTUBATION PRIOR TO ENDOSCOPIC REMOVAL IN ORDER TO PREVENT PULMONARY ASPIRATION OF THE BALLOON CONTENTS. ADDITIONALLY, IN SITUATIONS IN WHICH CONTROLLED BALLOON ASPIRATION IS DONE, IT IS RECOMMENDED THAT MID-STREAM FLUID ASPIRATED FROM THE BALLOON IS SENT FOR BACTERIAL AND FUNGAL CULTURES. PATIENTS WITH AN IGB THAT PRESENT WITH SEVERE ABDOMINAL PAIN THAT HAVE A NEGATIVE ENDOSCOPY AND X-RAY MAY ADDITIONALLY REQUIRE A CT SCAN TO DEFINITIVELY RULE OUT A PERFORATION. POSSIBLE ADVERSE EVENTS POSSIBLE ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE IGB INCLUDE: INTESTINAL OBSTRUCTION BY THE IGB. AN INSUFFICIENTLY FILLED IGB OR A LEAKING IGB THAT HAS LOST SUFFICIENT VOLUME MAY BE ABLE TO PASS FROM THE STOMACH INTO THE SMALL BOWEL. IT MAY PASS ALL THE WAY INTO THE COLON AND BE PASSED WITH STOOL. HOWEVER, IF THERE IS A NARROW AREA IN THE BOWEL OR ADHESION FORMATION, WHICH MAY OCCUR AFTER PREVIOUS SURGERY ON THE BOWEL, THE IGB MAY NOT PASS AND COULD CAUSE A BOWEL OBSTRUCTION. IF THIS OCCURS, SURGERY OR ENDOSCOPIC REMOVAL COULD BE REQUIRED. INJURY TO THE DIGESTIVE TRACT DURING PLACEMENT OF THE IGB 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. CONTINUING NAUSEA AND VOMITING. THIS COULD RESULT FROM DIRECT IRRITATION OF THE LINING OF THE STOMACH, DELAYED GASTRIC EMPTYING AND/OR THE IGB BLOCKING THE OUTLET OF THE STOMACH. IT IS EVEN THEORETICALLY POSSIBLE THAT THE IGB COULD PREVENT VOMITING (NOT NAUSEA OR RETCHING) BY BLOCKING THE INLET TO THE STOMACH FROM THE ESOPHAGUS. INJURY TO THE LINING OF THE DIGESTIVE TRACT AS A RESULT OF DIRECT CONTACT WITH THE ENDOSCOPE, THE IGB, 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. ADDITIONAL INFORMATION: THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE INVESTIGATOR IS WAITING UNTIL THE LOT NUMBER OF THE DEVICE IS KNOWN TO DETERMINE WHETHER A DEVICE HISTORY RECORD (DHR) REVIEW IS OR IS NOT REQUIRED FOR THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    SUPPLEMENT #01 MEDWATCH SUBMITTED TO THE FDA ON 10/APR/2023. ADDITIONAL INFORMATION: THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, AND AFTER MULTIPLE ATTEMPTS TO GATHER MORE INFORMATION FROM THE REPORTER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. THE INVESTIGATOR DETERMINED A DEVICE HISTORY RECORD (DHR) REVIEW IS NOT POSSIBLE FOR THIS COMPLAINT, AS ATTEMPTS AT GATHERING THE DEVICE SERIAL/LOT NUMBER WERE UNSUCCESSFUL. DEVICE EVALUATION SUMMARY: 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.

    Description of Event or Problem · 0

    AFTER 16 MOTHS OF HAVING THE BALLOON REMOVED THE PATIENT REPORT THAT WHILE THE BALLOON WAS IMPLANTED THAT SHE WAS HAVING BLACKOUT DUE TO THE BALLOON WAS PUSHING AGAINST HER VAGAL NERVE. THE PATIENT WAS EXPERIANCING DEHYDRATED AND WHEN THE PATIENT WAS HYDRATED SHE DID NOT EXPERIANCE ANY OTHER BLACKOUT. THE PATIENT HAS OTHER MEDICAL CONDITIONS THAT THE DOCTOR STATED WITHOUT LETTING US KNOW THISE CONDITIONS.THE PATIENT WAS IN THE HOSPITAL FOR TWO WEEKS WITH THE BALLOON STILL IMPLANTED WITHOUT ANY BLACKOUTS. BALLOON WAS REMOVED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935248 ORBERA365¿ INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON SYSTEM LTI APOLLO ENDOSURGERY, INC B-50012

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Hospitalization