BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENDITURE LAA EXCLUSION SYSTEM

    MDR report key: 23474857 · Received November 5, 2025

    Report

    Report Number
    2184009-2025-01419
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 24, 2025
    Report Date
    December 18, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    PZX
    UDI-DI
    00763000959890
    PMA / PMN Number
    K232295
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FDC CODE UPDATED 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.

    Additional Manufacturer Narrative · 0

    B.5.MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT ARTERIES WERE NOT BYPASSED. THEY ONLY USED ONE CLIP DEVICE. IT IS UNKNOWN WHETHER THE CIRCUMFLEX BRANCH WAS PINCHED BY THE CLIP OR WHETHER IT WAS NARROWED BY NEIGHBORING TISSUES. AFTER THE RE-OPERATION, NOTHING HAD BEEN PERFORMED AS THE PATIENT IS IN THE ICU. THE PLACEMENT POSITION INTERFERED WITH THE CX FOR SOME FACTOR, AND THERE WAS NO BLOOD FLOW BEYOND THAT POINT. NOTHING HAD BEEN PERFORMED FOR THE LCX. 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.

    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

    MEDTRONIC RECEIVED INFORMATION THAT AFTER THE USE OF A PENDITURE CLIP, IT WAS REPORTED THAT THE CLIP WAS IMPLANTED THROUGH A MICS (MINIMALLY INVASIVE CARDIAC SURGERY) FOR AN AVR (AORTIC VALVE REPLACEMENT), MVR (MITRAL VALVE REPAIR) AND LAAC (LEFT ATRIAL APPENDAGE CLOSURE) VIA MAZE ON (B)(6) 2025. CARDIAC FUNCTION RECOVERY AFTER THE OPERATION WAS NOT SUFFICIENT, THEREFORE, THE PATIENT WAS PLACED ON ECMO (EXTRA CORPOREAL MEMBRANE OXYGENATION) AND TRANSFERRED TO THE ICU (INTENSIVE CARE UNIT), HOWEVER, WHEN A CAG (CORONARY ANGIOGRAM) WAS PERFORMED ON (B)(6) 2025, IT WAS DISCOVERED THAT THERE WAS NO BLOOD FLOW IN THE CORONARY ARTERY (AHEAD OF CX (CIRCUMFLEX ARTERY)) AFTER THE CLIP IMPLANT POSITION. A THROMBUS WAS ALSO CONFIRMED IN THE LEFT ATRIUM AND LEFT VENTRICLE, AND THE OPERATION WAS PERFORMED AGAIN. A NEW DEVICE WAS OPENED, THE CLIP IMPLANTED IN THE BODY WAS REMOVED, THEN THE THROMBUS INSIDE THE LEFT ATRIUM AND LEFT VENTRICLE WAS REMOVED AND THE PROCEDURE WAS COMPLETED. THE CLIP IS NOT CURRENTLY IMPLANTED IN THE BODY. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER BELIEVED THAT THE CAUSE OF NO BLOOD FLOW IN THE LCX (LEFT CIRCUMFLEX CORONARY ARTERY) WAS DUE TO THE PLACEMENT POSITION OF THE PENDITURE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT IS CURRENTLY IN THE ICU ON ECMO. THEY STATED THAT THE PATIENT WILL LIKELY BE ABLE TO BE TAKEN OFF ECMO THIS WEEK. THE DEVICE WAS DEPLOYED ON A BEATING HEART. A SIZER WAS USED TO DETERMINE THE PENDITURE SIZE. THE SITE OF INSERTION WAS A RIGHT THORACOTOMY, SPECIFICALLY INTO THE RIGHT 4TH INTERCOSTAL SPACE. THERE WERE NO ABNORMALITIES WITH THE APPENDAGES (DEVICE, CLIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2492305 PENDITURE LAA EXCLUSION SYSTEM LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE PZX PERFUSION SYSTEMS LAAC45 T5F017X 00763000959890

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H