BEUDAMED
    FDA Adverse Event Death Summary report: N

    ORBERA365 INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 20428531 · Received October 11, 2024

    Report

    Report Number
    3005099803-2024-05041
    Event Type
    Death
    Date Received
    October 11, 2024
    Date of Event
    August 24, 2024
    Report Date
    February 11, 2025
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    LTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: PATIENT CODE E2327 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF NECROSIS. IMPACT CODE F02 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF DEATH.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON JANUARY 17, 2025. BLOCK A3 (GENDER), BLOCK B5 (EVENT DESCRIPTION), AND BLOCK H6 (PATIENT CODES AND IMPACT CODES) WERE UPDATED BASED ON ADDITIONAL INFORMATION. BLOCK H6: PATIENT CODE E2327 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF NECROSIS. IMPACT CODE F02 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF DEATH. IMPACT CODE F08 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF HOSPITALIZATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION BLOCK B2, B3, B5, G2 AND H6 (PATIENT CODES AND IMPACT CODES) WERE UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED ON OCTOBER 22, 2024. BLOCK H6: PATIENT CODE E2327 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF NECROSIS. IMPACT CODE F02 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF DEATH. IMPACT CODE F08 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF HOSPITALIZATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ORBERA365 INTRAGASTRIC BALLOON SYSTEM WAS IMPLANTED ON AN UNKNOWN DATE. ON SEPTEMBER 19, 2024, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOLLOWING IMPLANTATION, THE PATIENT HAD NECROSIS OF THE STOMACH. ON (B)(6) 2024 THE PHYSICIAN REPORTED THAT THE PATIENT PASSED AWAY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORBERA365 INTRAGASTRIC BALLOON SYSTEM WAS IMPLANTED ON AN UNKNOWN DATE. ON SEPTEMBER 19, 2024, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOLLOWING IMPLANTATION, THE PATIENT HAD NECROSIS OF THE STOMACH. ON (B)(6) 2024 THE PHYSICIAN REPORTED THAT THE PATIENT PASSED AWAY. ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 22, 2024, CLARIFYING THAT THE ORBERA365 BALLOON IMPLANTATION PROCEDURE OCCURRED ON (B)(6) 2024, WITHOUT ANY COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME AFTER PLACEMENT. ON (B)(6) 2024, THE PATIENT PRESENTED TO A HOSPITAL WITH ABDOMINAL PAIN IN THE NETHERLANDS. ***ADDITIONAL INFORMATION RECEIVED ON JANUARY 17, 2025*** THE PATIENT IS A FEMALE IN HER 60'S WITH A BMI OF 33. THE PATIENT HAD NO PREVIOUS SURGICAL HISTORY OR BARIATRIC PROCEDURES AND NO MEDICAL HISTORY OTHER THAN OBESITY. ON (B)(6) 2024, THE BALLOON WAS IMPLANTED AND FILLED TO 500 ML 0.9% NS SOLUTION. THE PATIENT WAS DISCHARGED AND TRAVELED FROM GERMANY TO HER HOME IN THE NETHERLANDS. THE NEXT DAY SHE INFORMED THE PHYSICIAN THAT SHE WAS HAVING ABDOMINAL PAIN AND VOMITING. ON DAY TWO THE PATIENT BECAME ILL AND REPORTED TO THE HOSPITAL WHERE SHE DEVELOPED ACUTE DECOMPENSATION AND FOUND TO BE IN SHOCK. AN INITIAL CT SCAN WAS PERFORMED WHICH REVEALED FLUID IN THE STOMACH. AN EMERGENCY GASTRECTOMY WAS PERFORMED ON THE DAY SHE WAS PRESENTED TO THE HOSPITAL. DURING THE PROCEDURE THEY FOUND THAT THE PATIENT HAD NECROSIS OF THE STOMACH. THE PATIENT DID WELL WITH THE SURGERY. ADDITIONAL CT ANGIOGRAM WAS PERFORMED AND FOUND UNREMARKABLE RESULTS. LATER DURING THE HOSPITAL STAY THE PATIENT'S CONDITION DETERIORATED RELATED TO SUTURE INSUFFICIENCY. THE PATIENT PASSED AWAY TWO WEEKS LATER ON (B)(6) 2024.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORBERA365 INTRAGASTRIC BALLOON SYSTEM WAS IMPLANTED ON AN UNKNOWN DATE. ON (B)(6) 2024, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOLLOWING IMPLANTATION, THE PATIENT HAD NECROSIS OF THE STOMACH. ON (B)(6), 2024 THE PHYSICIAN REPORTED THAT THE PATIENT PASSED AWAY. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 22, 2024. CLARIFYING INFORMATION RECEIVED STATING THAT THE ORBERA365 BALLOON IMPLANTATION PROCEDURE OCCURRED ON (B)(6) 2024, IN GERMANY, WITHOUT ANY COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME AFTER PLACEMENT. ON (B)(6), 2024, THE PATIENT PRESENTED TO A HOSPITAL WITH ABDOMINAL PAIN IN THE NETHERLANDS AND PASSED AWAY ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336179 ORBERA365 INTRAGASTRIC BALLOON SYSTEM IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI APOLLO ENDOSURGERY B-50012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death| R| H| O