BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVERSTITCH ENDOSCOPIC SUTURING SYSTEM

    MDR report key: 8701844 · Received June 14, 2019

    Report

    Report Number
    3006722112-2019-00131
    Event Type
    Death
    Date Received
    June 14, 2019
    Date of Event
    January 1, 2017
    Report Date
    May 17, 2019
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    OCW
    PMA / PMN Number
    K081853
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENT #1 - MEDWATCH SUBMITTED TO THE FDA ON 25/MAR/2020

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION HAS BEEN REQUESTED FROM THE PRESENTER REGARDING: ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT, PHYSICIAN INFORMATION, PATIENT INFORMATION, AND DEVICE INFORMATION. THE PRESENTOR INDICATED THAT THEY HAD NOT SEEN THIS PATIENT, AND THAT THEY WOULD NOT PROVIDE THE NAME OF THE PATIENT'S TREATING PHYSICIAN. A REVIEW OF THE INSTRUCTIONS FOR USE NOTES THE FOLLOWING: WARNINGS: ONLY PHYSICIANS POSSESSING SUFFICIENT SKILL AND EXPERIENCE IN SIMILAR OR THE SAME TECHNIQUES SHOULD PERFORM ENDOSCOPIC PROCEDURES. ADVERSE EVENTS POSSIBLE COMPLICATIONS THAT MAY RESULT FROM USING THE ENDOSCOPIC SUTURING SYSTEM INCLUDE, BUT MAY NOT BE LIMITED TO: · DEATH

    Description of Event or Problem · 1

    REPORTED DURING A MEDICAL CONFERENCE PRESENTATION: A PATIENT WHO UNDERWENT AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) UTILIZING THE OVERSTITCH ENDOSCOPIC SUTURING SYSTEM WAS NOTED TO HAVE DIED (PULMONARY EMBOLISM). ADDITIONAL INFORMATION REPORTED, "PATIENT DID WELL AFTER THE PROCEDURE. [THEY WERE] SEEN IN CLINIC ON DAY 2 WITHOUT ANY COMPLAINT. HOWEVER, 5 DAYS AFTER THE PROCEDURE [THE PATIENT] DIED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492773 OVERSTITCH ENDOSCOPIC SUTURING SYSTEM SUTURING SYSTEM OCW APOLLO ENDOSURGERY, INC. ESS-G02-160 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death