BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

    MDR report key: 11576140 · Received March 26, 2021

    Report

    Report Number
    9610612-2021-00314
    Event Type
    Injury
    Date Received
    March 26, 2021
    Date of Event
    February 18, 2021
    Report Date
    December 2, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    FZP
    UDI-DI
    04046955241026
    PMA / PMN Number
    K202124
    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

    INVESTIGATION RESULTS: VISUAL INVESTIGATION: THE DEVICE IS IN A USED CONDITION. IN SIMILAR CASES LIKE THE PRESENT ONE, THE INVESTIGATION DID NOT REVEAL ANY ABNORMALITIES ON THE PAS-PORT DEVICE AND THE INDIVIDUAL PARTS ITSELF. NO DAMAGES COULD BE FOUND WHICH MAY EXPLAIN THE FAILURE PATTERN. ON THE BASIS OF THE CURRENT INFORMATION AND KNOWLEDGE, A CLEAR CONCLUSION CANNOT BE DRAWN. THEREFORE, A PRODUCT SAFETY CASE (PSC) HAS BEEN INITIATED TO EVALUATE THE RISK-BENEFIT RATIO, REF. PSC-2020-033. THE EVALUATION RESULTED IN A FIELD SAFETY CORRECTIVE ACTION (FSCA), REF. FSCA-255. A RECALL HAS BEEN INITIATED. DUE TO THE AFOREMENTIONED, AN IN-DEPTH INVESTIGATION IS WAIVED. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY X PROBABILITY OF OCCURRENCE) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. A PRODUCT RECALL WAS INITIATED IN 2021. THE DEVICES WERE NOT MARKETED ANY LONGER.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO AESCULAP AG THAT A PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM (PART # FC700SU) WAS USED DURING A OFF-PUMP CORONARY ARTERY BYPASS (OPCAB) PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE INNER FLANGE ONLY PARTIALLY DEPLOYED. REPORTED, AFTER THE KNOB WAS ROTATED, THE INNER FLANGE WAS ONLY PARTIALLY DEPLOYED AND ONLY A HOLE WAS MADE IN THE AORTA. HEART STRING WAS INSERTED INTO THE HOLE MADE BY PPS CUTTER AND ANASTOMOSIS WAS PERFORMED TO COMPLETE THE PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED OR MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473356 PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM ANASTOMOSIS DEVICES FZP AESCULAP AG FC700SU 52624646 04046955241026

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention