BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENDITURE LAA EXCLUSION SYSTEM

    MDR report key: 23665970 · Received November 27, 2025

    Report

    Report Number
    2184009-2025-01547
    Event Type
    Injury
    Date Received
    November 27, 2025
    Date of Event
    July 11, 2025
    Report Date
    February 27, 2026
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    PZX
    UDI-DI
    00763000791452
    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

    ADDITIONAL INFO B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT ADVERSE EFFECT CRF (CHRONIC RENAL FAILURE) 001 (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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THE ADVERSE EVENT WAS DEEMED NOT RELATED TO THE CLIP DEVICE PER SITE, SPONSOR AND CEC ASSESSMENT. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803.¿ 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 THROUGH THE CLIP-IT CLINICAL POST-MARKET STUDY, THAT FOLLOWING A PROCEDURE INVOLVING USE OF THE PENDITURE CLIP ON (B)(6) 2024, THE CUSTOMER REPORTED THAT THE PATIENT HAD A TRANSIENT ISCHAEMIC ATTACK (TIA) ON (B)(6) 2025, AND IT WAS SUCCESSFULLY TREATED WITH A NEW HOSPITALIZATION (START DATE-(B)(6) 2025, END DATE- (B)(6) 2025). THE ADVERSE EVENT (AE) WAS TREATED WITH AN IMPLANTABLE CARDIAC RHYTHM DEVICE ON (B)(6) 2025 AS THE PATIENT WAS AT RISK FOR A CARDIAC EMBOLIC EVENT. THE DEVICE WAS AN IMPLANTABLE LOOP RECORDER. A CONCOMITANT MEDICATION WAS ADMINISTERED OR ADJUSTED DUE TO THIS AE. DIAGNOSTIC TESTS AND A NEUROLOGICAL EVALUATION WERE PERFORMED. THE NEUROLOGICAL SYMPTOMS RESOLVED WITHIN 24 HOURS. THERE WAS A RAPID ONSET OF FOCAL OR GLOBAL NEUROLOGICAL DEFICIT. THE PATIENT HAD PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH RIGHT ARM WEAKNESS. AN MRI (MAGNETIC RESONANCE IMAGING) WITH ACUTE TO SUBACUTE STROKE (CVA) IN LEFT POSTERIOR FRONTAL LOBE WAS OBSERVED. THE SYMPTOMS RESOLVED IN 15 MINUTES. THE PATIENT WAS STARTED ON PLAVIX AND CONTINUED ASPIRIN. THEY WERE DISCHARGED HOME. THE NEUROLOGY NOTE AT DISCHARGED STATED THAT AN ATHEROTHROMBOTIC EVENT WAS MOST LIKELY THE CAUSE. THE PATIENT FOLLOWED UP WITH THE CARDIOLOGIST ON (B)(6) 2025 WHO WAS CONCERNED ABOUT A CARDIAC EMBOLIC EVENT OCCURRING. THE OUTCOME OF THE ADVERSE EVENT IS THAT THE PATIENT RECOVERED/RESOLVED, AND THE PATIENT HAS BEEN HOSPITALIZED SINCE (B)(6) 2025. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE PENDITURE CLIP DEVICE, BUTNOT RELATED TO THE PENDITURE DELIVERY SYSTEM. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS POSSIBLY RELATED TO THE PENDITURE CLIP DEVICE, BUT NOT RELATED TO THE PENDITURE DELIVERY SYSTEM. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT ADVERSE EFFECT CRF (CHRONIC RENAL FAILURE) 001 (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 RECEIVED ADDITIONAL INFORMATION THAT ADVERSE EFFECT 001 (START DATE-(B)(6) 2025). THE ADVERSE EVENT (ISCHEMIC STROKE) WAS DEEMED BY THE SITE AS NOT RELATED TO THE PENDITURE CLIP DEVICE.

    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) 2024, THE CUSTOMER REPORTED THAT THE PATIENT HAD A TRANSIENT ISCHAEMIC ATTACK (TIA) ON (B)(6) 2025, AND IT WAS SUCCESSFULLY TREATED WITH A NEW HOSPITALIZATION (START DATE- (B)(6) 2025). THE ADVERSE EVENT (AE) WAS TREATED WITH AN IMPLANTABLE CARDIAC RHYTHM DEVICE ON (B)(6) 2025 AS THE PATIENT WAS AT RISK FOR A CARDIAC EMBOLIC EVENT. THE DEVICE WAS AN IMPLANTABLE LOOP RECORDER. A CONCOMITANT MEDICATION WAS ADMINISTERED OR ADJUSTED DUE TO THIS AE. DIAGNOSTIC TESTS AND A NEUROLOGICAL EVALUATION WERE PERFORMED. THE NEUROLOGICAL SYMPTOMS RESOLVED WITHIN 24 HOURS. THERE WAS A RAPID ONSET OF FOCAL OR GLOBAL NEUROLOGICAL DEFICIT. THE PATIENT HAD PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH RIGHT ARM WEAKNESS. AN MRI (MAGNETIC RESONANCE IMAGING) WITH ACUTE TO SUBACUTE STROKE (CVA) IN LEFT POSTERIOR FRONTAL LOBE WAS OBSERVED. THE SYMPTOMS RESOLVED IN 15 MINUTES. THE PATIENT WAS STARTED ON PLAVIX AND CONTINUED ASPIRIN. THEY WERE DISCHARGED HOME. THE NEUROLOGY NOTE AT DISCHARGED STATED THAT AN ATHEROTHROMBOTIC EVENT WAS MOST LIKELY THE CAUSE. THE PATIENT FOLLOWED UP WITH THE CARDIOLOGIST ON (B)(6) 2025 WHO WAS CONCERNED ABOUT A CARDIAC EMBOLIC EVENT OCCURRING.  THE OUTCOME OF THE ADVERSE EVENT IS THAT THE PATIENT RECOVERED/RESOLVED, AND THE PATIENT HAS BEEN HOSPITALIZED SINCE (B)(6) 2025.  THE ADVERSE EVENT WAS DEEMED BY THE SITE 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 POSSIBLY RELATED TO THE PENDITURE CLIP DEVICE, BUT NOT RELATED TO THE PENDITURE DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154727 PENDITURE LAA EXCLUSION SYSTEM LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE PZX PERFUSION SYSTEMS LAAC40 T4A075X 00763000791452

    Patients

    Seq Age Sex Outcome Treatment
    1