BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 14986212 · Received July 12, 2022

    Report

    Report Number
    2134265-2022-07765
    Event Type
    Injury
    Date Received
    July 12, 2022
    Date of Event
    March 22, 2022
    Report Date
    April 13, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANT DATE - ESTIMATED SINCE EXACT DATE UNKNOWN.

    Additional Manufacturer Narrative · 0

    D6A: IMPLANT DATE - ESTIMATED SINCE EXACT DATE UNKNOWN. LITERATURE CITATION: JOSEPH, M., CARSON, O., MICHAEL, K., STEPHANIE, Y., & DONALD, C. (2022). EXPLANT OF A THROMBOSED WATCHMAN DEVICE AFTER 48 DAYS. ANNALS OF VASCULAR SURGERY-BRIEF REPORTS AND INNOVATIONS, 2(4), 100146.

    Description of Event or Problem · 0

    IT WAS REPORTED THROMBUS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 31MM WATCHMAN FLX LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED. AT THE 45 DAY FOLLOW UP, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING REVEALED MULTIPLE BLOOD CLOTS ON THE CLOSURE DEVICE. OPEN HEART SURGERY WAS PERFORMED AND THE CLOSURE DEVICE WAS EXPLANTED. THE PATIENT WAS ALSO TAKEN OFF XARELTO. MEDWATCH # MW5110052.

    Description of Event or Problem · 0

    IT WAS REPORTED THROMBUS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 31MM WATCHMAN FLX LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED. AT THE 45 DAY FOLLOW UP, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING REVEALED MULTIPLE BLOOD CLOTS ON THE CLOSURE DEVICE. OPEN HEART SURGERY WAS PERFORMED AND THE CLOSURE DEVICE WAS EXPLANTED. THE PATIENT WAS ALSO TAKEN OFF XARELTO. MEDWATCH # MW5110052. IT WAS FURTHER REPORTED VIA JOURNAL ARTICLE THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AND STARTED ON IV HEPARIN. AFTER DISCUSSION, THE PATIENT WAS PLANNED FOR TRANSSEPTAL DEBULKING WITH CEREBRAL PROTECTION THE NEXT MORNING GIVEN SIGNIFICANT MOBILITY OF THE THROMBI. PERIOPERATIVE TEE DEMONSTRATED MULTIPLE NEW AND WORSENING THROMBI ON THE CLOSURE DEVICE. GIVEN THE PATIENTS RAPID THROMBI PROGRESSION WHILE ON HEPARIN, THE DECISION WAS MADE TO CONVERT THE PROCEDURAL PLAN AND PROCEED WITH EMERGENT STERNOTOMY, OPEN THROMBECTOMY, AND DEVICE REMOVAL. AFTER THE CLOSURE DEVICE AND THROMBI WERE REMOVED, THE LAA WAS LIGATED. A SEPARATE AORTOTOMY WAS PERFORMED AND A SINGLE THROMBUS LOCATED ON THE HINGE POINT OF THE RIGHT AORTIC CUSP WAS REMOVED. A POST-PROCEDURE TEE DID NOT DEMONSTRATE ANY ADDITIONAL THROMBI. THE PATIENTS POST-OP WORKUP WAS NEGATIVE FOR ANY COAGULATION DISORDERS, AND THE PATIENT WAS SUBSEQUENTLY DISCHARGED HOME ON WARFARIN. LITERATURE CITATION: JOSEPH, M., CARSON, O., MICHAEL, K., STEPHANIE, Y., & DONALD, C. (2022). EXPLANT OF A THROMBOSED WATCHMAN DEVICE AFTER 48 DAYS. ANNALS OF VASCULAR SURGERY-BRIEF REPORTS AND INNOVATIONS, 2(4), 100146.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701540 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0028096101 08714729860518

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention