BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENDITURE LAA EXCLUSION SYSTEM

    MDR report key: 19792974 · Received July 22, 2024

    Report

    Report Number
    2184009-2024-00418
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    June 24, 2024
    Report Date
    July 22, 2024
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    PZX
    PMA / PMN Number
    K232295
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    MEDTRONIC RECEIVED INFORMATION THAT THE CUSTOMER IMPLANTED A PENDITURE LAA CLIP AS PART OF A CONCOMITANT LEFT ATRIAL APPENDAGE (LAA) EXCLUSION DURING AN AORTIC VALVE REPLACEMENT. AFTER THE HEART WAS ARRESTED AND THE PATIENT WAS ON CARDIOPULMONARY BYPASS, THE SURGEON INSTRUCTED THE FELLOW TO PLACE THE DEVICE. THE FELLOW PLACED THE CLIP ON THE LAA UNDER THE DOCTOR'S SUPERVISION WITHOUT AN EVENT AND CONTINUED WITH THE SURGERY TO REPLACE THE PATIENT'S AORTIC VALVE, ALSO WITHOUT EVENT. AFTER CLOSING THE PATIENT'S CHEST, THE CUSTOMER REALIZED THERE WAS A LARGER THAN NORMAL AMOUNT OF BLOOD COMING OUT OF THE CHEST TUBES. THE CUSTOMER DECIDED TO RE-EXPLORE THE HEART TO DETERMINE WHERE THE BLEEDING WAS COMING FROM. THE DOCTOR PLACED SEVERAL LAP PADS INTO THE PATIENT'S CHEST AND SAW THAT BRIGHT RED, OXYGENATED BLOOD WAS APPARENT ON THE LAPS BEHIND THE HEART. HOWEVER, THEY COULD NOT LOCATE THE SOURCE OF THE BLEEDING. THE BLEEDING SEEMED TO HAVE SUBSIDED AFTER GIVING THE PATIENT PLATELETS AND OTHER PRODUCTS TO ASSIST WITH THE COAGULOPATHY. THE DOCTOR DECIDED TO PUT FLO SEAL ON THE POTENTIAL BLEEDING SITES AND SUBSEQUENTLY CLEANSED AND RINSED OUT THE CHEST CAVITY UNTIL THEY WERE ASSURED THAT THERE WAS NO RESIDUAL BLEEDING. THE CUSTOMER THEN CLOSED THE CHEST A SECOND TIME AND THE PATIENT WAS SENT TO THE CARDIAC ICU FOR RECOVERY. IT WAS REPORTED THAT THE BLEEDING HAD STOPPED, AND THE PATIENT WAS DOING GREAT. IT WAS ALSO REPORTED THAT THE DOCTOR PLANNED TO USE PENDITURE ON THEIR SECOND CASE THAT FOLLOWED. THE CLIP WAS VIEWED AS A POSSIBLE CULPRIT AS IT WAS A NEW VARIABLE IN A SURGERY WHERE THE PATIENT BLED. THE ANESTHESIOLOGIST EXPLAINED THAT THE MORE LIKELY CAUSE OF THE BLEEDING WAS THE SUTURE LINE OF THE AORTOTOMY. THE CUSTOMER STATED THAT THE BLEEDING COULD HAVE COME FROM A VARIETY OF CAUSES AND THAT THEY WERE NOT CERTAIN THAT THE CLIP CAUSED THE BLEEDING OR WHERE THE BLEEDING CAME FROM. THE CUSTOMER ELECTED NOT TO USE THE DEVICE ON THE NEXT CASE DUE TO THEIR SUSPICIONS REGARDING THE CAUSE OF THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188995 PENDITURE LAA EXCLUSION SYSTEM LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE PZX PERFUSION SYSTEMS LAAC35 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention