BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENDITURE LAA EXCLUSION SYSTEM

    MDR report key: 23776602 · Received December 11, 2025

    Report

    Report Number
    2184009-2025-01607
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 11, 2025
    Report Date
    December 11, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    PZX
    UDI-DI
    00763000959906
    PMA / PMN Number
    K232295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE INVOLVING THE PENDITURE CLIP, THE CLIP DID NOT FULLY EXCLUDE THE APPENDAGE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO PLACEMENT ISSUES. THE CONCOMITANT PROCEDURE WAS MAZE. THE CLIP WAS DEPLOYED ON A BEATING HEART. THE IMPLANT TECHNIQUE AND SITE OF INSERTION WAS LEFT ATRIAL APPENDAGE. THERE WAS NOTHING UNUSUAL ABOUT THE APPENDAGE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER KNEW THE CLIP WAS NOT EXCLUDING AS THERE WAS BLEEDING FROM A DECOMPRESSED APPENDAGE. THEY USED A SIZER. THE IMPLANT TECHNIQUE WAS A STANDARD OPEN EXCLUSION TECHNIQUE. THEY DID NOT REPLACE WITH A PENDITURE DEVICE. THE PATIENT WAS VERY YOUNG. THE BLEEDING OCCURRED INTRA OPERATIVELY AND THE SURGEON REPLACED IT WITH ANOTHER COMPANY¿S CLIP WHICH RESULTED IN THE STOPPAGE OF BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2772486 PENDITURE LAA EXCLUSION SYSTEM LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE PZX PERFUSION SYSTEMS LAAC50 T5G073X 00763000959906

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male