BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN® ACCESS SYSTEM

    MDR report key: 5739738 · Received June 21, 2016

    Report

    Report Number
    2134265-2016-05378
    Event Type
    Death
    Date Received
    June 21, 2016
    Date of Event
    May 26, 2016
    Report Date
    May 27, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    UPN - SEARCH: UPDATED FROM UNK728 - WATCHMAN ACCESS SYSTEM - (B)(4) - WATCHMAN ACCESS SYS DOUBLE. UPN: UPDATED FROM UNK728 TO M635TC20060. PMA# OR 510K#: UPDATED FROM M110009 TO P130013. DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF THE WATCHMAN ACCESS SYSTEM (WAS) ALONG WITH A DILATOR AND WATCHMAN DELIVERY SYSTEM (WDS) LOT # ON RELATED COMPLAINT. BLOOD WAS ON THE DEVICE AND THE VALVE WAS CLOSED AS RECEIVED. THE HUB, VALVE, SHAFT, AND TIP WERE EXAMINED. THERE WERE MULTIPLE KINKS ALONG THE SHAFT OF THE DEVICE. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2016-05374. IT WAS REPORTED THAT PERICARDIAL EFFUSION WITH TAMPONADE OCCURRED AND THE PATIENT DIED. IT WAS REPORTED THAT A PERFORATION, PERICARDIAL EFFUSION WITH TAMPONADE AND DEATH OCCURRED. THE PATIENT WAS UNDERGOING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. A 24MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM WAS ADVANCED INTO A WATCHMAN ACCESS SYSTEM AND POSITIONED FOR DEPLOYMENT. "THE TREND TENSION OF THE SHEATH SYSTEM WAS BIG." WHEN THE PHYSICIAN RELEASED THE CLOSURE DEVICE, THE WALL OF THE LAA WAS PERFORATED. A PERICARDIAL EFFUSION WITH CARDIAC TAMPONANDE OCCURRED. THE PHYSICIAN PERFORMED A PERICARDIAL FLUID ASPIRATION, BUT IT WAS UNSUCCESSFUL. THE PATIENT WAS SENT FOR THORACOTOMY SURGERY TO REPAIR THE LAA. AT THIS TIME THE PATIENT'S HEART RATE AND BLOOD PRESSURE RETURNED TO NORMAL. THE PHYSICIAN LIGATED THE LAA. POST PROCEDURE, THE PATIENT'S VITAL SIGNS WERE STABLE, BUT SHE DID NOT REGAIN CONSCIOUSNESS. THE FOLLOWING DAY, THE PATIENT DIED.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2016-05374. IT WAS REPORTED THAT A PERFORATION, PERICARDIAL EFFUSION WITH TAMPONADE AND DEATH OCCURRED. THE PATIENT WAS UNDERGOING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. A 24MM WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM WAS ADVANCED INTO A WATCHMAN ® ACCESS SYSTEM AND POSITIONED FOR DEPLOYMENT. "THE TREND TENSION OF THE SHEATH SYSTEM WAS BIG." WHEN THE PHYSICIAN RELEASED THE CLOSURE DEVICE, THE WALL OF THE LAA WAS PERFORATED. A PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE OCCURRED. THE PHYSICIAN PERFORMED A PERICARDIAL FLUID ASPIRATION, BUT IT WAS UNSUCCESSFUL. THE PATIENT WAS SENT FOR THORACOTOMY SURGERY TO REPAIR THE LAA. AT THIS TIME THE PATIENT¿S HEART RATE AND BLOOD PRESSURE RETURNED TO NORMAL. THE PHYSICIAN LIGATED THE LAA. POST PROCEDURE, THE PATIENT'S VITAL SIGNS WERE STABLE, BUT SHE DID NOT REGAIN CONSCIOUSNESS. THE FOLLOWING DAY, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392346 WATCHMAN® ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635TC20060 18298552

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death| R