BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE

    MDR report key: 21815651 · Received April 10, 2025

    Report

    Report Number
    3005687633-2025-00106
    Event Type
    Death
    Date Received
    April 10, 2025
    Date of Event
    February 17, 2025
    Report Date
    July 16, 2025
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWR
    PMA / PMN Number
    P150011S013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: THE DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. FDA PREMARKET SUBMISSION NUMBER OF SIMILAR DEVICE: P150011 (SUPPLEMENT NUMBER 013); PRIMARY DI NUMBER FOR SIMILAR DEVICE: (B)(4). THE MANUFACTURING AND MATERIAL RECORDS FOR THE DEVICE INVOLVED IN THIS EVENT, AS THEY PERTAIN TO THE REPORTED ISSUE, WERE RETRIEVED AND REVIEWED BY THE MANUFACTURER¿S QUALITY ENGINEERING. THE RESULTS CONFIRMED THAT THIS PROSTHESIS SATISFIED ALL REQUIRED MATERIAL, VISUAL, AND PERFORMANCE STANDARDS AT THE TIME OF MANUFACTURE AND RELEASE. THE MANUFACTURER IS FOLLOWING UP WITH THE HEALTHCARE FACILITY TO RETRIEVE ADDITIONAL INFORMATION ON THE REPORTED EVENT AND THE DEVICE INVOLVED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ANY NEW INFORMATION OR AT THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER IS CONTINUING EFFORTS TO FOLLOW UP ON THE EVENT, THE DEVICE INVOLVED, AND THE PATIENT'S RISK FACTORS AND MEDICAL CONDITIONS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ANY ADDITIONAL INFORMATION OR UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: H6. SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THE MANUFACTURER COULD NOT PERFORM FURTHER INVESTIGATION ON THE INVOLVED PERCEVAL PROSTHESIS. ALTHOUGH ONLY LIMITED INVESTIGATIONS COULD BE CONDUCTED, BASED ON THE MEDICAL JUDGMENT PROVIDED, IT IS REASONABLE TO CONCLUDE THAT THE EVENT WAS DUE TO SURGICAL COMPLICATIONS RELATED TO THE AVR PROCEDURE AND NOT ASSOCIATED WITH THE PERCEVAL VALVE.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2025, A PATIENT UNDERWENT AORTIC VALVE REPLACEMENT WITH A PERCIVAL PLUS SUTURELESS AORTIC BIOPROSTHESIS SIZE SMALL. THE VALVE WAS NEEDED TO BE EXPLANTED DUE TO LVOT RUPTURE AND EXCESSIVE BLEEDING. BASED ON FURTHER INFORMATION RECEIVED, THE PATIENT REMAINED STABLE THROUGHOUT THE SURGERY. HOWEVER, THE PATIENT'S CONDITION DETERIORATED DURING THE RE-EXPLORATION PERIOD, ULTIMATELY LEADING TO THEIR PASSING. ACCORDING TO MEDICAL JUDGEMENT, LVOT RUPTURE MIGHT HAVE OCCURRED WHILE TAKING THE NADIR SUTURES AND DURING DECALCIFICATION. THE MANUFACTURER HAS BEEN INFORMED THAT THE INVOLVED DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED AT THE HOSPITAL FACILITY.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2025, A PATIENT UNDERWENT AORTIC VALVE REPLACEMENT WITH A PERCEVAL PLUS SUTURELESS AORTIC BIOPROSTHESIS SIZE SMALL. THE VALVE WAS NEEDED TO BE EXPLANTED DUE TO LVOT RUPTURE AND EXCESSIVE BLEEDING. BASED ON FURTHER INFORMATION RECEIVED, THE PATIENT REMAINED STABLE THROUGHOUT THE SURGERY. HOWEVER, THE PATIENT'S CONDITION DETERIORATED DURING THE RE-EXPLORATION PERIOD, ULTIMATELY LEADING TO THEIR PASSING. ACCORDING TO MEDICAL JUDGEMENT, LVOT RUPTURE MIGHT HAVE OCCURRED WHILE TAKING THE NADIR SUTURES AND DURING DECALCIFICATION. THE MANUFACTURER HAS BEEN INFORMED THAT THE INVOLVED DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED AT THE HOSPITAL FACILITY. ADDITIONALLY, IT HAS BEEN CONFIRMED THAT AN AUTOPSY WAS NOT PERFORMED.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2025; A PATIENT UNDERWENT AORTIC VALVE REPLACEMENT WITH A PERCEVAL PLUS SUTURELESS AORTIC BIOPROSTHESIS SIZE SMALL. THE VALVE WAS NEEDED TO BE EXPLANTED DUE TO LVOT RUPTURE AND EXCESSIVE BLEEDING. BASED ON FURTHER INFORMATION RECEIVED, THE PATIENT REMAINED STABLE THROUGHOUT THE SURGERY. HOWEVER, THE PATIENT'S CONDITION DETERIORATED DURING THE RE-EXPLORATION PERIOD, ULTIMATELY LEADING TO THEIR PASSING. THE MANUFACTURER WAS INFORMED THAT AN AUTOPSY WAS NOT PERFORMED. ACCORDING TO MEDICAL JUDGEMENT, LVOT RUPTURE MIGHT HAVE OCCURRED WHILE TAKING THE NADIR SUTURES AND DURING DECALCIFICATION. ADDITIONALLY, THE SURGEON DETERMINED THAT THE EVENT WAS DUE TO SURGICAL COMPLICATIONS UNRELATED TO THE PERCEVAL VALVE. THE MANUFACTURER HAS BEEN INFORMED THAT THE INVOLVED DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED AT THE HOSPITAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816690 PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR CORCYM S.R.L. PVF-S

    Patients

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