BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER TORQVUE 45X45 DELIVERY SHEATH

    MDR report key: 21360606 · Received February 11, 2025

    Report

    Report Number
    2135147-2025-00685
    Event Type
    Injury
    Date Received
    February 11, 2025
    Date of Event
    January 19, 2025
    Report Date
    March 3, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQY
    UDI-DI
    05415067025906
    PMA / PMN Number
    K163000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    AN EVENT OF PATIENT DEVICE INTERACTION PROBLEM ASSOCIATED WITH THROMBUS WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION RECEIVED, THE REPORTED PATIENT DEVICE INTERACTION PROBLEM WITH THROMBUS COULD NOT BE DETERMINED. THE REPORTED MINOR INJURY/ILLNESS/IMPAIRMENT WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING, DESIGN, OR MANUFACTURING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM AMPLATZER AMULET WAS SELECTED FOR IMPLANT USING A 14F AMPLATZER TORQVUE DELIVERY SYSTEM (LOT: 9115457). COMPUTED TOMOGRAPHY (CT) AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS USED TO DETERMINE THE SIZE. DURING PROCEDURE, AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS TO IMPLANT THE AMULET DUE TO BEING TOO LARGE WITH SUBOPTIMAL POSITION, IT WAS REMOVED. THE 31MM AMULET WAS EXCHANGED FOR A NEW 28MM AMPLATZER AMULET (LOT: 9051988). THE SHEATH WAS NOT EXCHANGED PER PHYSICIAN PREFERENCE AND ASPIRATED. THE 28MM AMULET WAS UNSHEATHED TO BALL, BUT WAS NOT DEPLOYED AS A SMALL THROMBUS WAS OBSERVED AT THE TIP OF THE SHEATH. NO DEPLOYMENTS WERE ATTEMPTED WITH THIS DEVICE AND IT WAS WITHDRAWN FROM THE SHEATH. THE SHEATH WAS AGAIN ASPIRATED, BUT AGAIN NOT EXCHANGED DUE TO PHYSICIAN PREFERENCE. ANOTHER NEW 28MM AMPLATZER AMULET (LOT: 8875300) WAS SELECTED AND ATTEMPTED TO BE IMPLANTED, HOWEVER THIS WAS UNSUCCESSFUL DUE TO SUBOPTIMAL POSITION AND WAS REMOVED FROM THE PATIENT. A NEW TRANSSEPTAL PUNCTURE (TSP) WAS ELECTED TO OPTIMIZE THE APPROACH; THE NEW TSP PROVIDED A MORE FAVORABLE APPROACH. A THIRD NEW 28MM AMPLATZER AMULET (LOT: 8898897) WAS SELECTED FOR IMPLANT USING A NEW 14F AMPLATZER TORQVUE DELIVERY SYSTEM (LOT: 10256632). THE THIRD 28MM AMULET WAS PLACED AND PASSED TENSION TEST. TEE ASSESSMENT WAS COMPLETED. SECOND TENSION WAS PERFORMED TO ENSURE DEVICE STABILITY AND CLOSE CRITERIA WAS ACHIEVED. THE DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT'S CONDITION POST-IMPLANT WAS STABLE AND WELL. ON (B)(6) 2025, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH PULMONARY EDEMA AND COUGHING WITH BLOODY SPUTUM. THE PHYSICIAN SUSPECTED DEVICE EMBOLIZATION. ON 20 JANUARY 2025, THE PATIENT PASSED AWAY DUE TO UNKNOWN CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164129 AMPLATZER TORQVUE 45X45 DELIVERY SHEATH CATHETER, PERCUTANEOUS DQY ABBOTT MEDICAL 9115457 05415067025906

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other