BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVERSTITCH ENDOSCOPIC SUTURE SYSTEM

    MDR report key: 19281855 · Received May 9, 2024

    Report

    Report Number
    3005099803-2024-01945
    Event Type
    Death
    Date Received
    May 9, 2024
    Date of Event
    April 11, 2024
    Report Date
    June 11, 2024
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    OCW
    UDI-DI
    20811955020661
    PMA / PMN Number
    K181141
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. IMDRF CODE F23: CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION. IMDRF CODE F2303: CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMDRF CODE E0602: CAPTURES THE REPORTABLE EVENT OF CARDIAC ARREST. IMDRF CODE E130501: CAPTURES THE REPORTABLE EVENT OF RENAL INSUFFICIENCY/FAILURE. IMDRF CODE E050303: CAPTURES THE REPORTABLE EVENT OF EMBOLISM, PULMONARY. BLOCK H6: IMDRF CODE E0102 CAPTURES THE REPORTABLE EVENT OF BRAIN INJURY. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR PRODUCT ANALYSIS. LABELING LABEL REVIEW A LABELING REVIEW WAS PERFORMED USING WITH THE INSTRUCTIONS FOR USE (IFU). THE IFU CONTAINS DETAILED DEVICE INFORMATION AND INSTRUCTIONS FOR THE DEVICE USE. ADDITIONALLY, IT WAS CONFIRMED THAT THE FOLLOWING ADVERSE EVENTS ARE ANTICIPATED IN THE IFU: PAIN, ABDOMINAL, EMBOLISM, PULMONARY AND DEATH. ALSO, THERE IS NO EVIDENCE THE DEVICE WAS IMPROPERLY USED PER THE IFU, AND THERE IS NO EVIDENCE THAT THERE IS ANY ISSUE WITH TRANSLATION, WORDING, OR GRAPHICS OF THE IFU/LABELING INFORMATION. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF "PAIN, ABDOMINAL, EMBOLISM, PULMONARY, CARDIAC ARREST, RENAL INSUFFICIENCY/FAILURE, BRAIN INJURY, UNEXPECTED MEDICAL INTERVENTION, MEDICATION REQUIRED, IMAGING REQUIRED, HOSPITALIZATION OR PROLONGED HOSPITALIZATION AND DEATH" WERE DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. ACCORDING TO A MEDICAL REVIEW, THE EVENT OF "DEATH" IS ACCOUNTED FOR WITHIN THE HAZARD ANALYSIS, INFORMATION FOR USERS, AND CLINICAL EVALUATION REPORT IN NATURE AND SEVERITY AND DOES NOT REQUIRE ESCALATION TO SENIOR MANAGEMENT. DEVICE HISTORY RECORD (DHR) REVIEW: IT WAS CONFIRMED THIS DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INVESTIGATION CONCLUSION: FOR THE AS REPORTED PAIN, ABDOMINAL, EMBOLISM, PULMONARY AND DEATH THESE ADVERSE EVENTS ARE KNOWN AND DOCUMENTED IN THE LABELING AND ALL REASONABLE STEPS HAVE BEEN TAKEN (INCLUDING BOTH SHORT OR LONG TERM KNOWN COMPLICATIONS OR ADVERSE REACTIONS), FOR THIS REASON THESE EVENTS ARE CATALOGUED AS "KNOWN INHERENT RISK OF DEVICE."

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. IMDRF CODE F23: CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION. IMDRF CODE F2303: CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMDRF CODE E0602: CAPTURES THE REPORTABLE EVENT OF CARDIAC ARREST. IMDRF CODE E130501: CAPTURES THE REPORTABLE EVENT OF RENAL INSUFFICIENCY/FAILURE. IMDRF CODE E050303: CAPTURES THE REPORTABLE EVENT OF EMBOLISM, PULMONARY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED FOR A 64-YEAR-OLD FEMALE PATIENT WHO UNDERWENT AN ENDOSCOPIC SLEEVE GASTROPLASTY FOR WEIGHT LOSS ON (B)(6) 2024. THE PHYSICIAN REPORTED THAT THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA AND WAS UNEVENTFUL. POST OPERATIVE CARE WAS AS EXPECTED, WITH THE PATIENT TOLERATING CLEAR FLUIDS AND AMBULATING BEFORE DISCHARGE. ON THE SAME DATE, IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SUDDEN ONSET EPIGASTRIC PAIN. ECG WAS PERFORMED AND WAS UNREMARKABLE, ELEVATED BLOOD PRESSURE WAS NOTED. NO OTHER IMAGING OR LAB WORK WAS TAKEN. PATIENT WAS GIVEN ORAL ANALGESIA AND DISCHARGED HOME. ON (B)(6) 2024, THE PATIENT CONFIRMED SHE WAS TOLERATING 30ML SIPS OF FLUIDS AND WAS PAIN FREE. ON THE EVENING OF (B)(6) 2024, THE PATIENT SUFFERED A CARDIAC ARREST AT THEIR RESIDENCE. PARAMEDICS WERE ABLE TO STABILIZE THE PATIENT, HOWEVER SHE WENT ON TO HAVE FURTHER MULTIPLE CARDIAC ARRESTS IN THE EMERGENCY DEPARTMENT. A NON-CONTRAST CT WAS PERFORMED (NON-CONTRAST DUE TO ACUTE RENAL FAILURE) AT SIX (6) HOURS AFTER THE FIRST CARDIAC ARREST, WHICH SHOWED SEVERE ANOXIC BRAIN INJURY, BRAIN STEM HERNIATION, MINIMAL CHEST ASPIRATION. ABDOMINAL IMAGING SHOWED SOME SMALL AIR POCKETS AROUND THE LIVER AND PELVIS. NO OVERSTITCH ENDOSCOPIC SUTURE SYSTEM ISSUE WAS REPORTED DURING OR AFTER THE PROCEDURE. THE OVERSTITCH ENDOSCOPIC SUTURE SYSTEM HAS BEEN DISPOSED. NO AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE PERFORMED ON (B)(6) 2024. POST PROCEDURE ON (B)(6) 2024, THE PATIENT PRESENTED TO THE ER WITH EPIGASTRIC PAIN AND WAS DISCHARGED AFTER DOSE OF ORAL PAIN MEDICATION. THE PATIENT EXPERIENCED CARDIAC ARREST ON (B)(6) 2024 AND EXPIRED (B)(6) 2024. NO DEVICE ISSUE WAS REPORTED DURING OR AFTER THE PROCEDURE. THE DEVICE HAS BEEN DISPOSED. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484553 OVERSTITCH ENDOSCOPIC SUTURE SYSTEM ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW APOLLO ENDOSURGERY ESS-G02-160 20811955020661

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| O| R| D