BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 19014762 · Received April 1, 2024

    Report

    Report Number
    2135147-2024-01450
    Event Type
    Death
    Date Received
    April 1, 2024
    Date of Event
    January 1, 2018
    Report Date
    May 22, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT RETURNING FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PATIENT EFFECTS AND MALFUNCTIONS REPORTED IN THE ARTICLE ARE CAPTURED UNDER SEPARATE MEDWATCH REPORTS. LITERATURE: ARTICLE TITLE "SAFETY AND EFFECTIVENESS OF CONCOMITANT MITRAL TRANSCATHETER EDGE-TO-EDGE REPAIR AND LEFT ATRIAL APPENDAGE CLOSURE".

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) AND COMPLAINT HISTORY REVIEWS WERE NOT PERFORMED BECAUSE THIS INCIDENT WAS BASED ON AN ARTICLE REVIEW AND NO LOT INFORMATION WAS PROVIDED. BASED ON AVAILABLE INFORMATION AND DUE TO THE LIMITED INFORMATION AVAILABLE FROM THE ARTICLE, THE CAUSE OF THE REPORTED EXPULSION AND POOR IMAGE RESOLUTION WERE UNABLE TO BE DETERMINED. ADDITIONALLY, THE REPORTED PATIENT EFFECTS OF DEATH/EXPIRED, ANEURYSM, CEREBROVASCULAR ACCIDENT, HEMATOMA, FISTULA, HEMORRHAGE, EMBOLISM, HEART FAILURE, MITRAL STENOSIS, AND THROMBUS, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED PATIENT EFFECTS OF DEATH/EXPIRED, ANEURYSM, CEREBROVASCULAR ACCIDENT, HEMATOMA, FISTULA, HEMORRHAGE, EMBOLISM, HEART FAILURE, MITRAL STENOSIS, AND THROMBUS CANNOT BE DETERMINED. THE REPORTED HOSPITALIZATION, SURGICAL INTERVENTION, AND UNEXPECTED MEDICAL INTERVENTION WERE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. LITERATURE ATTACHMENT: ARTICLE TITLE ¿SAFETY AND EFFECTIVENESS OF CONCOMITANT MITRAL TRANSCATHETER EDGE-TO-EDGE REPAIR AND LEFT ATRIAL APPENDAGE CLOSURE".

    Description of Event or Problem · 0

    THE ARTICLE, "SAFETY AND EFFECTIVENESS OF CONCOMITANT MITRAL TRANSCATHETER EDGE-TO-EDGE REPAIR AND LEFT ATRIAL APPENDAGE CLOSURE", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY AIMED AT REPORTING SAFETY AND MID-TERM OUTCOMES OF CONCOMITANT MITRAL TRANSCATHETER EDGE-TO-EDGE REPAIR (M-TEER) AND LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURES, COMPARING THEM TO THOSE OF PATIENTS UNDERGOING ISOLATED M-TEER THROUGHOUT THE SAME PERIOD. DEVICES INCLUDED IN THE STUDY WERE AMPLATZER AMULET, WATCHMAN FLX, AND MITRACLIP. THE ARTICLE CONCLUDED THAT PATIENTS WITH CONCOMITANT MITRAL REGURGITATION AND ATRIAL FIBRILLATION AND ELIGIBLE FOR M-TEER AND LAAC TREATMENT, A COMBINED APPROACH OF M-TEER AND LAAC WAS AS SAFE AS AN M-TEER-ALONE STRATEGY AND ASSOCIATED WITH LOWER MINOR BLEEDING AT 1 YEAR. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MARCO BARBANTI, DIVISION OF CARDIOLOGY, A.O.U. POLICLINICO ¿G. RODOLICO SAN MARCO¿, 95123 CATANIA, ITALY, WITH CORRESPONDING EMAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2018 TO DECEMBER 2022. A TOTAL OF 99 PATIENTS WERE INCLUDED IN THE STUDY. OF THE PATIENTS WHO UNDERWENT LAAC PROCEDURE, ONLY ONE RECEIVED AN AMPLATZER AMULET. OF THE PATIENTS WHO UNDERWENT M-TEER, 97.9% RECEIVED A MITRACLIP DEVICE. THE AVERAGE AGE WAS 79 YEARS AND THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED HYPERTENSION, DIABETES MELLITUS, DYSLIPIDEMIA, CHRONIC KIDNEY DISEASE, PRIOR STROKE, PRIOR TRANSIENT ISCHEMIC ATTACK, PRIOR PERCUTANEOUS CORONARY INTERVENTION, PRIOR CORONARY ARTERY BYPASS GRAFT, CORONARY ARTERY DISEASE, PRIOR MYOCARDIAL INFARCTION, DEGENERATIVE/FUNCTIONAL MITRAL REGURGITATION. (B)(6), UNK AMPLATZER AMULET PERI- AND POST-PROCEDURAL COMPLICATIONS INCLUDED DEVICE RELATED THROMBUS, HEMATOMA (B)(6), UNK MITRACLIP DELIVERY SYSTEM INTRA PROCEDURE COMPLICATIONS INCLUDED PSEUDOANEURYSM, HEMATOMA, SURGICAL INTERVENTION, FISTULA, UNEXPECTED MEDICAL INTERVENTION, MITRAL STENOSIS, CLIP DETACHMENT, POOR IMAGING. PERI AND POST PROCEDURAL COMPLICATIONS INCLUDED DEATH, STROKE, SYSTEMIC EMBOLISM, BLEEDING/HEMORRHAGE, HEART FAILURE, HOSPITALIZATION, THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566460 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death