BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX PRO

    MDR report key: 21607395 · Received March 14, 2025

    Report

    Report Number
    2124215-2025-15806
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    February 28, 2025
    Report Date
    May 6, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004606
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDIA EVALUATED BY BSC MEDICAL SAFETY: MEDIA FROM THE CLINICAL PROCEDURE WAS PROVIDED AND REVIEWED BY A MEMBER OF THE BSC GLOBAL MEDICAL SAFETY ORGANIZATION. THE MEDIA REVIEW REPORT CONCLUDED: THE AVAILABLE MEDIA WAS LIMITED AND ONLY TWO STILL IMAGES WERE SUBMITTED FOR REVIEW. ONE WAS A FLUOROSCOPY IMAGE THAT SHOWED THE WATCHMAN FXD CURVE ACCESS SYSTEM SHEATH, BUT NO OTHER CONCLUSION COULD BE MADE. THE OTHER WAS A TEE IMAGE THAT SHOWED THE EMBOLIZED DEVICE IN THE LEFT VENTRICLE POSITIONED SIDEWAYS IN THE LEFT VENTRICLE OUTFLOW TRACT. DEVICE EVALUATED BY MFR.: A WATCHMAN FLX PRO DELIVERY SYSTEM (WDS) WITH THE IMPLANT IN A SEPARATE CONTAINER WAS RETURNED FOR DEVICE ANALYSIS. THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL INSPECTION REVEALED NUMEROUS KINKS IN THE SHEATH AND BLOOD IN THE DEVICE. MICROSCOPIC EXAMINATION REVEALED DAMAGE OCCURRED AS A RESULT OF FACTORS ENCOUNTERED DURING THE PROCEDURE. PRODUCT AND MEDIA ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT AS CLINICAL CIRCUMSTANCES COULD NOT BE REPLICATED. THERE WAS TIP DAMAGE AS THE TRI-CUTS WERE FLARED, THE DISTAL MARKER BAND WAS KINKED, AND THERE WERE ABRASIONS WITHIN THE SHEATH TIP, WHICH IS CONSISTENT WITH DEPLOYING AND RECAPTURING THE IMPLANT. THE OBSERVED DAMAGE WAS ATTRIBUTED TO PROCEDURAL FACTORS AS THE MOST LIKELY CAUSE OF THE DAMAGE IS DUE TO THE FORCES THAT ARE PUT UPON THE DEVICE DURING INSERTION, ADVANCING, AND MANIPULATION.

    Additional Manufacturer Narrative · 0

    MEDIA EVALUATED BY BSC MEDICAL SAFETY: MEDIA FROM THE CLINICAL PROCEDURE WAS PROVIDED AND REVIEWED BY A MEMBER OF THE BSC GLOBAL MEDICAL SAFETY ORGANIZATION. THE MEDIA REVIEW REPORT CONCLUDED: THE AVAILABLE MEDIA IS LIMITED AND ONLY 2 STILL IMAGES HAVE BEEN SUBMITTED FOR REVIEW. ONE WAS A FLUORO IMAGE SHOWING THE FXD ACCESS SHEATH, BUT NO OTHER CONCLUSION CAN BE MADE. THE OTHER IS A TEE IMAGE SHOWING THE EMBOLIZED DEVICE IN THE LV POSITIONED SIDEWAYS IN THE LVOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PREMATURE DEVICE DETACHMENT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS), VERSACROSS CONNECT (VCC) AND A 27MM WATCHMAN FLX PRO CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE 27MM WATCHMAN FLX PRO CLOSURE DEVICE WAS PREPARED AND ADVANCED INTO THE PATIENT. UPON FIRST DEPLOYMENT INTO THE LAA, WHEN THE WAS COMPLETELY UNSHEATHED, THE CLOSURE DEVICE PREMATURELY RELEASED FROM THE CORE WIRE AND EMBOLIZED INTO THE LEFT VENTRICLE. THE CLOSURE DEVICE WAS PERCUTANEOUSLY RETRIEVED FROM THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) USING AN 18F, 33CM NON-BOSTON SCIENTIFIC (BSC) SHEATH AND LASSO SNARE. THE PATIENT WAS DISCHARGED AND WILL RETURN AT A LATER DATE FOR A REPEAT LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PREMATURE DEVICE DETACHMENT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS), VERSACROSS CONNECT (VCC) AND A 27 MM WATCHMAN FLX PRO CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE 27 MM WATCHMAN FLX PRO CLOSURE DEVICE WAS PREPARED AND ADVANCED INTO THE PATIENT. UPON FIRST DEPLOYMENT INTO THE LAA, WHEN THE WAS WAS COMPLETELY UNSHEATHED, THE CLOSURE DEVICE PREMATURELY RELEASED FROM THE CORE WIRE AND EMBOLIZED INTO THE LEFT VENTRICLE. THE CLOSURE DEVICE WAS PERCUTANEOUSLY RETRIEVED FROM THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) USING AN 18F, 33 CM NON-BOSTON SCIENTIFIC (BSC) SHEATH AND LASSO SNARE. THE PATIENT WAS DISCHARGED AND WILL RETURN AT A LATER DATE FOR A REPEAT LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399001 WATCHMAN FLX PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60270 0035420136 00191506004606

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention| O