BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENDITURE LAA EXCLUSION SYSTEM

    MDR report key: 23244975 · Received October 8, 2025

    Report

    Report Number
    2184009-2025-01301
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    September 16, 2025
    Report Date
    February 20, 2026
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    PZX
    PMA / PMN Number
    K232295
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS POSSIBLY RELATED TO THE PENDITURE CLIP DEVICE. 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

    ADDITIONAL INFO B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT ADVERSE EFFECT CRF (CHRONIC RENAL FAILURE) 003 (START DATE (B)(6) 2025). THE ADVERSE EVENT WAS DEEMED BY CEC AS NOT RELATED" TO CLIP AND DELIVERY SYSTEM. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS NOT RELATED TO THE PENDITURE CLIP DEVICE, AND NOT RELATED TO THE PENDITURE DELIVERY SYSTEM 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 THROUGH THE CLIP-IT CLINICAL POST-MARKET STUDY, THAT FOLLOWING A PROCEDURE INVOLVING USE OF THE PENDITURE CLIP ON (B)(6) 2025 (8 MONTHS POST IMPLANT), THE CUSTOMER REPORTED THAT THE PATIENT HAD A TRANSIENT ISCHEMIC ATTACK ON (B)(6) 2025, AND THE AE RESULTED IN THE NEW HOSPITALIZATION FOR THE SUBJECT, AND LED TO SERIOUS DETERIORATION IN THE HEALTH OF THE SUBJECT. DIAGNOSTIC TEST WAS PERFORMED, AND NEUROLOGICAL EVALUATION WAS ALSO PERFORMED, AND THIS RESOLVED ISSUE WITHIN 24 HOURS. THERE WAS A RAPID ONSET OF FOCAL OR GLOBAL NEUROLOGICAL DEFICIT ON (B)(6) 2025, PATIENT WAS ON THE WAY TO BATHROOM AND NOTED HIS LEFT LEG WAS WEAK AND "SHAKING". HE LATER NOTED HIS LEFT HAND/ARM WAS SLIGHTLY NUMB. PATIENT WENT TO ER BUT UPON ARRIVAL SYMPTOMS HAD RESOLVED. CT HEAD AND CTA HEAD AND NECK WITH NO ACUTE FINDINGS. MRI DONE SHOWED NO ACUTE ABNORMALITY. PATIENT CONTINUED WITH ASPIRIN AND XARELTO. PATIENT DISCHARGED HOME ON (B)(6) 2025. THE OUTCOME OF THE ADVERSE EVENT IS RECOVERED/ RESOLVED, ON (B)(6) 2025. THE ADVERSE EVENT WAS DEEMED BY THE INVESTIGATOR AS POSSIBLY RELATED TO THE PENDITURE CLIP DEVICE, BUT NOT RELATED TO THE PENDITURE DELIVERY SYSTEM. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS NOT RELATED TO THE PENDITURE CLIP DEVICE, AND NOT RELATED TO THE PENDITURE DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2585909 PENDITURE LAA EXCLUSION SYSTEM LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE PZX PERFUSION SYSTEMS LAAC40 T4G041X

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization| L