BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 13489589 · Received February 8, 2022

    Report

    Report Number
    1219930-2022-00479
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    September 27, 2021
    Report Date
    May 23, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: LEFT ATRIAL APPENDAGE ELIMINATION TECHNIQUES: STAPLED EXCISION VERSUS INTERNAL SUTURE OBLITERATION SOURCE: J THORAC DIS 2021;13(11):6252-6260 / HTTPS://DX.DOI.ORG/10.21037/JTD-21-1138. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT A PHOTO WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THERE WERE FOUR TOTAL FIGURES EACH CONSISTING OF THREE DIFFERENT TYPES OF IMAGING. THE FIRST FIGURE SHOWED A COMPLETELY EXCISED LEFT ATRIAL APPENDAGE. THE SECOND FIGURE SHOWED ANOTHER COMPLETELY OBLITERATED LEFT ATRIAL APPENDAGE. THE THIRD AND FOURTH FIGURES SHOW FAILED LEFT ATRIAL APPENDAGE EXCISIONS/OBLITERATIONS. THE STAPLE LINE IS NOT OBSERVED IN THE FIGURES. THERE APPEARS TO BE BLEEDING IN THE FIGURES. IT WAS REPORTED THAT UNEXPECTED BLEEDING OCCURRED ALONG THE STAPLE LINE. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE SOURCE OF RETROSPECTIVE STUDY PERFORMED FROM 2013 TO 2020 EVALUATED OUTCOMES OF LEFT ATRIUM APPENDAGE ELIMINATION IN 158 PATIENTS BY EITHER A STAPLED EXCISION (SE) IN 102 PATIENTS OR INTERNAL SUTURE OBLITERATION (IO) IN 56 PATIENTS. VASCULAR STAPLERS OF 60MM AND 45MM WERE USED. NON-COMPANY SUTURE WAS USED FOR THE IO GROUP. REPORTED COMPLICATIONS INCLUDED 8 INSTANCES OF STAPLE LINE BLEEDING AND 4 INSTANCES OF SURROUNDING TISSUE REQUIRING SUTURE REINFORCEMENT DURING THE PROCEDURE. UNRELATED COMPLICATIONS INCLUDED ACUTE KIDNEY INJURY, LOW CARDIAC OUTPUT SYNDROME, RESPIRATORY COMPLICATIONS, EMBOLIC STROKE, REOPERATIONS UNRELATED TO STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896558 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Other