BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 15374923 · Received September 7, 2022

    Report

    Report Number
    2124215-2022-34839
    Event Type
    Injury
    Date Received
    September 7, 2022
    Date of Event
    January 1, 2022
    Report Date
    September 7, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WANG S, ZHANG J, HAO S, ZHU L, NING ZAND ZHAO Z (2022) PERCUTANEOUS RETRIEVAL OF LEFT ATRIAL APPENDAGE CLOSURE DEVICES. IN PATIENTS WITH ATRIAL FIBRILLATION: A CASE REPORT. FRONT. CARDIOVASC. MED. 9:905344. DOI: 10.3389/FCVM.2022.905344.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT DEVICE EMBOLIZATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE PATIENT HAD A HISTORY OF TAKING WARFARIN BUT HAD SELF-DISCONTINUED THE MEDICATION. TRANSTHORACIC ECHOCARDIOGRAPHY REVEALED THE FOLLOWING FINDINGS: LEFT ATRIUM (LA), 44 MM; (LV) END-SYSTOLE, 46 MM; LV END-DIASTOLIC, 55MM; LV EJECTION FRACTION, 58%; MITRAL CALCIFICATION WITH MINIMAL REGURGITATION; AND MINIMAL AORTIC REGURGITATION. BOTH THE CHA2DS2-VASC AND HAS-BLED SCORE WERE 6 POINTS. LA COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXCLUDED LA THROMBUS. THE PATIENT UNDERWENT A COMBINATION OF CATHETER ABLATION AND LEFT ATRIAL APPENDAGE CLOSURE IN A SINGLE PROCEDURE. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) MEASURED AN LAA OSTIAL OF 25-30MM AND AN EFFECTIVE DEPTH OF 28MM. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) MEASURED THE LAA OPENING AS 28MM AND THE DEPTH AS 31MM. THE WATCHMAN 33MM DEVICE WAS RELEASED, WITH A COMPRESSION RATIO OF 15-24% AND NO RESIDUAL PERI-DEVICE LEAK. AF PULMONARY VEIN ISOLATION ABLATION WAS THEN PERFORMED. AFTER RETURNING TO THE RECOVERY ROOM, THE PATIENT DEVELOPED A COUGH AND SHORTNESS OF BREATH. BEDSIDE ECHOCARDIOGRAPHY DID NOT SHOW THE WATCHMAN DEVICE, AND A CHEST CT SCAN REVEALED THAT THE WATCHMAN WAS IN THE AORTIC ARCH. A 5-FRENCH (FR) ANGIOGRAPHY CATHETER WAS SENT THROUGH THE RADIAL ARTERY TO THE AORTIC ARCH FOR RELATIVE FIXATION OF THE WATCHMAN. NEXT, THE 5-FR PIGTAIL ANGIOGRAPHY CATHETER WAS SENT THROUGH THE 6-FR SHEATH OF THE LEFT FEMORAL ARTERY TO THE RIGHT FEMORAL ARTERY PUNCTURE SITE TO DELINEATE TO ENSURE THAT THE PUNCTURE SITE WAS LOCATED IN THE MIDDLE OF THE FEMORAL ARTERY. AFTER A SUCCESSFUL PUNCTURE OF THE RIGHT FEMORAL ARTERY, TWO NON-BOSTON SCIENTIFIC (BSC) CLOSURE DEVICES WERE PRE -SET AT THE PUNCTURE SITE. A WATCHMAN GUIDE SYSTEM 16-FR SHEATH WAS SENT UNDER THE WATCHMAN IMPLANT THROUGH THE FEMORAL ARTERY, AND A 7-FR GUIDE CATHETER WAS SENT THROUGH THE SHEATH TO THE OCCLUDING UMBRELLA. NEXT, THE NON-BSC SNARE, A 20 OR 40-MM MESH BASKET GUIDEWIRE, WERE CAUGHT AND COVERED. THE WATCHMAN WAS PULLED DOWN TO THE DESCENDING AORTA. THEN, THE 2.4-MM X 20-C NON BSC GRASPING DEVICE WAS ADVANCED THROUGH THE 16-FR SHEATH INTO THE LA TO CLAMP TRABECULAE OF THE UMBRELLA. AFTER INTRATHECAL INJECTION OF ICE-COLD 0.9% SALINE, THE VASCULAR SHEATH WAS PUSHED, THE OCCLUDING UMBRELLA WAS RECOVERED INTO THE SHEATH AND THE WATCHMAN IMPLANT WAS REMOVED. WHEN THE VASCULAR SHEATH WAS WITHDRAWN, THE FEMORAL ARTERY WAS SUTURED WITH A NON-BSC CLOSURE DEVICE AT THE PUNCTURE SITE OF THE FEMORAL ARTERY. THEN, THE PATIENT WAS RETURNED TO RECOVERY SAFELY, AND LAAC WAS PERFORMED AGAIN 5 MONTHS LATER. IN THIS LATER SURGERY, THE 33-MM WATCHMAN WAS PLACED, AND DIGITAL SUBTRACTION ANGIOGRAPHY (DSA), AND TEE CONFIRMED THAT THE WATCHMAN DEVICE WAS PROPERLY POSITIONED. THE COMPRESSION RATIO WAS 15-20% AND THERE WAS NO RESIDUAL LEAKAGE. THE POSTOPERATIVE FOLLOW-UP RE-EXAMINATION OF TEE WAS NORMAL. SIX MONTHS LATER, A CHEST CT SHOWED THAT THE WATCHMAN WAS IN A GOOD POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255736 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention