BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVERSTITCH ENDOSCOPIC SUTURE SYSTEM

    MDR report key: 19524828 · Received June 12, 2024

    Report

    Report Number
    3005099803-2024-02845
    Event Type
    Death
    Date Received
    June 12, 2024
    Date of Event
    September 24, 2023
    Report Date
    July 11, 2024
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    OCW
    UDI-DI
    20811955020661
    PMA / PMN Number
    K181141
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G6: TYPE OF REPORT FOLLOW UP # 4 FOR 3006722112-2023-00206. IMDRF CODE 9183 CAPTURES THE REPORTABLE EVENT OF MYOCARDIAL INFARCTION. IMDRF CODE 9046 CAPTURES THE REPORTABLE EVENT OF CEREBRAL VASCULAR ACCIDENT (CVA). IMDRF CODE 9069 CAPTURES THE EVENT OF DISCOMFORT. IMDRF CODE 9131 CAPTURES THE EVENT OF HEMORRHAGE, MINOR. IMDRF CODE F2203 CAPTURES THE EVENT OF IMAGING REQUIRED. CORRECTION: BLOCK H6: EVALUATION CONCLUSION CODE. ADDITIONAL INFORMATION: INFORMATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR PRODUCT ANALYSIS. LABELING REVIEW: A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. IT WAS CONFIRMED THAT THE FOLLOWING ADVERSE EVENTS OF HEMORRHAGE, MINOR AND DEATH ARE ANTICIPATED IN THE INSTRUCTION FOR USE (IFU). RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF "HEMORRHAGE, MINOR, MYOCARDIAL INFARCTION, CEREBRAL VASCULAR ACCIDENT (CVA), DISCOMFORT, DEATH AND IMAGING REQUIRED" WERE DEFINED IN THE RISK DOCUMENTATION AND IS DOCUMENTED ACCORDINGLY. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. DEVICE HISTORY RECORD (DHR) REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED SINCE THE SHIP HISTORY REVIEW WAS UNABLE TO BE COMPLETED. INVESTIGATION CONCLUSION: FOR THE AR HEMORRHAGE, MINOR AND DEATH THESE ADVERSE EVENTS ARE KNOWN AND DOCUMENTED IN THE LABELING AND ALL REASONABLE STEPS HAVE BEEN TAKEN. FOR THIS REASON THESE EVENTS ARE CATALOGUED AS "KNOWN INHERENT RISK OF DEVICE." THE INVESTIGATION CONCLUDED THAT, WITHOUT ANALYSIS OF THE DEVICE, THERE IS A LACK OF OBJECTIVE EVIDENCE OR DESCRIPTIVE CONDITIONS OF THE EVENT REQUIRED TO DETERMINE A DEFINITIVE ROOT CAUSE OF THE EVENT. THE INVESTIGATION FINDINGS AND ALL COMPILED INFORMATION AVAILABLE DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. THEREFORE, THE INVESTIGATION DETERMINES THAT THE MOST PROBABLE CAUSE IS CAUSE NOT ESTABLISHED.

    Additional Manufacturer Narrative · 0

    BLOCK G6: TYPE OF REPORT FOLLOW UP # 3 FOR 3006722112-2023-00206. BLOCK H1: TYPE OF REPORTABLE EVENT. BLOCK H6: IMDRF CODE 9183 CAPTURES THE REPORTABLE EVENT OF MYOCARDIAL INFARCTION, IMDRF CODE 9046 CAPTURES THE REPORTABLE EVENT OF CEREBRAL VASCULAR ACCIDENT (CVA), IMDRF CODE 9069 CAPTURES THE EVENT OF DISCOMFORT, IMDRF CODE 9131 CAPTURES THE EVENT OF HEMORRHAGE, MINOR, IMDRF CODE F2203 CAPTURES THE EVENT OF IMAGING REQUIRED. SUPPLEMENT 02 MEDWATCH SUBMITTED TO THE FDA ON 15/DEC/2023. A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: THE CURRENT OVERSTITCH ENDOSCOPIC SUTURING SYSTEM (ESS) INSTRUCTIONS FOR USE (IFU) ADDRESSED THE KNOWN AND POTENTIAL EVENT OF "DEATH" AS FOLLOWS: THE APOLLO ENDOSURGERY OVERSTITCH ENDOSCOPIC SUTURE SYSTEM (ESS) IS INTENDED FOR ENDOSCOPIC PLACEMENT OF SUTURE(S) AND APPROXIMATION OF SOFT TISSUE. THE OVERSTITCH IS COMPATIBLE WITH THE FOLLOWING ENDOSCOPES: OLYMPUS 2T160, 2TH180, OR 2T240 FUJI EI-740D/S AVAILABILITY OF COMPATIBLE DEVICES MAY VARY DEPENDING ON GEOGRAPHY. POSSIBLE COMPLICATIONS THAT MAY RESULT FROM USING THE ENDOSCOPIC SUTURING SYSTEM INCLUDE, BUT MAY NOT BE LIMITED TO: PHARYNGITIS / SORE THROAT NAUSEA AND / OR VOMITING ABDOMINAL PAIN AND / OR BLOATING HEMORRHAGE HEMATOMA CONVERSION TO LAPAROSCOPIC OR OPEN PROCEDURE STRICTURE INFECTION / SEPSIS PHARYNGEAL, COLONIC AND/OR ESOPHAGEAL PERFORATION ESOPHAGEAL, COLONIC AND/OR PHARYNGEAL LACERATION INTRA-ABDOMINAL (HOLLOW OR SOLID) VISCERAL INJURY ASPIRATION WOUND DEHISCENCE ACUTE INFLAMMATORY TISSUE REACTION DEATH NOTE: ANY SERIOUS INCIDENT THAT HAS OCCURRED IN RELATION TO THE DEVICE SHOULD BE REPORTED TO APOLLO ENDOSURGERY (SEE CONTACT INFORMATION AT THE END OF THIS DOCUMENT) AND ANY APPROPRIATE GOVERNMENT ENTITY. 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

    THIS EVENT WAS PREVIOUSLY REPORTED BY APOLLO ENDOSURGERY, INC. THE INITIAL (OCTOBER 30, 2023) AND SUPPLEMENTAL #1 (NOVEMBER 6, 2023) AND SUPPLEMENTAL #2 (DECEMBER 15, 2023) MEDWATCH REPORTS WERE SUBMITTED UNDER NUMBER 3006722112-2023-00206. REPORT OF PATIENT DEATH. IT WAS REPORTED THAT TWO WEEKS AFTER THE ESG PROCEDURE THAT THE PATIENT WAS NOT FEELING GOOD AND WENT TO THE ER AND A TAC SHOWED BLOOD AND LIQUID IN THE ABDOMEN RANGE. THE PATIENT WAS DISCHARGED FROM THE ER THE NEXT DAY, THE ER DISCHARGED THE PATIENT AND THE NEXT DAY THE PATIENT PASSED AWAY. APOLLO TRIED TO REACH OUT TO THE DOCTOR SEVERAL TIME AND THE DOCTOR DID NOT WANT TO DISCUSS THE CASE. AN AUTOPSY WAS PERFORMED BUT WE WERE NOT ALLOWED TO GET A COPY OF THE REPORT. THE TERRITORY SALE MANGER WAS INFORMED ABOUT SAYS THAT DEATH WAS TOLD THE CAUSE OF DEATH WAS NOT DUE TO THE DEVICE IT WAS DUE TO A HEART ATTACK / STROKE.

    Description of Event or Problem · 0

    THIS EVENT WAS PREVIOUSLY REPORTED BY APOLLO ENDOSURGERY, INC. THE INITIAL (OCTOBER 30, 2023) AND SUPPLEMENTAL #1 (NOVEMBER 6, 2023) AND SUPPLEMENTAL #2 (DECEMBER 15, 2023) MEDWATCH REPORTS WERE SUBMITTED UNDER NUMBER 3006722112-2023-00206. REPORT OF PATIENT DEATH. IT WAS REPORTED THAT TWO WEEKS AFTER THE ESG PROCEDURE THAT THE PATIENT WAS NOT FEELING GOOD AND WENT TO THE ER AND A TAC SHOWED BLOOD AND LIQUID IN THE ABDOMEN RANGE. THE PATIENT WAS DISCHARGED FROM THE ER THE NEXT DAY, THE ER DISCHARGED THE PATIENT AND THE NEXT DAY THE PATIENT PASSED AWAY. APOLLO TRIED TO REACH OUT TO THE DOCTOR SEVERAL TIME AND THE DOCTOR DID NOT WANT TO DISCUSS THE CASE. AN AUTOPSY WAS PERFORMED BUT WE WERE NOT ALLOWED TO GET A COPY OF THE REPORT. THE TERRITORY SALE MANGER WAS INFORMED ABOUT SAYS THAT DEATH WAS TOLD THE CAUSE OF DEATH WAS NOT DUE TO THE DEVICE IT WAS DUE TO AN HEART ATTACK / STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183711 OVERSTITCH ENDOSCOPIC SUTURE SYSTEM ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW APOLLO ENDOSURGERY ESS-G02-160 20811955020661

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Hospitalization| O| D