BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCYRUS MEDICAL DISSECTION STENT HYBRID PROSTHESIS

    MDR report key: 21791679 · Received April 7, 2025

    Report

    Report Number
    1063481-2025-00021
    Event Type
    Injury
    Date Received
    April 7, 2025
    Date of Event
    September 22, 2023
    Report Date
    June 20, 2025
    Manufacturer
    ASCYRUS MEDICAL GMBH
    Product Code
    QSK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THE HDE NUMBER FOR THIS DEVICE - (B)(4). THIS EVENT IS RELATED TO A POST-MARKET CLINICAL STUDY 'PROTECT' AND REPORTED RETROSPECTIVELY. A SAMPLE EVALUATION WAS NOT PERFORMED AS THE DEVICE REMAINS IMPLANTED. PATIENT IS A 59-YEAR-OLD MALE WHO HAD AN AMDS DEVICE (SIZE/LOT #: UNKNOWN) IMPLANTED ON (B)(6) 2019. ADVERSE EVENT REPORTED AS ¿GROWTH OF THE AORTIC ARCH¿ WITH AN ONSET DATE OF 30OCT2019 (3 DAYS POST-OP) WITH AN END DATE OF (B)(6) 2020. THE AE FORM DESCRIBED THE EVENT AS ¿NEGATIVE AORTIC REMODELING, AORTIC GROWTH DUE TO FALSE LUMEN PERFUSION.¿ THE EVENT WAS DEEMED ¿POSSIBLY¿ RELATED TO THE AMDS DEVICE AND ¿POSSIBLY¿ RELATED TO THE IMPLANT PROCEDURE. DEBAKEY TYPE A DISSECTION WAS LISTED AS THE PRE-EXISTING CONDITION OR ACUTE DISEASE THAT CAUSED OR CONTRIBUTED TO THE EVENT. THE EVENT LED TO A SERIOUS ADVERSE EVENT RESULTING IN A LIFE-THREATENING ILLNESS OR INJURY¿ AND MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR FUNCTION.¿ PERCUTANEOUS TREATMENT WAS PROVIDED AND THE EVENT OUTCOME WAS DOCUMENTED AS ONGOING. IT IS IMPORTANT TO NOTE THAT THE AMDS DEVICE WAS NOT REMOVED, AND THE PATIENT REMAINED IN THE STUDY. ADDITIONAL INFORMATION PROVIDED INDICATES THE PATIENT HAD THE FOLLOWING COMORBIDITIES: TIA ((B)(6) 2019) AND POLLEN ALLERGY. THE STUDY TEAM ALSO STATED THAT THE PATIENT UNDERWENT ¿TWO ADDITIONAL POST-OP PROCEDURES (TEVAR, DISSECTION- STENT AND E-NSIDE IMPLANTATIONS ON (B)(6) 2023; E-TEGRA AND E-LIAC BOTH SIDES ON (B)(6) 2023). CT IMAGES WERE PROVIDED. THE IMAGES WERE REVIEWED AND THE FOLLOWING SIGNIFICANT FINDING WAS DOCUMENTED: ¿THE CT DATA SHOWS THAT THE AORTIC ARCH HAS GROWN OVER THE YEARS. THE GROWTH OCCURRED IN THE FALSE LUMEN OF THE AORTA.¿ THE REVIEWER SELECTED ¿UNKNOWN¿ IN RESPONSE TO AGREEING WITH THE COMPLAINT DESCRIPTION AND NOTED THE FOLLOWING EXPLANATION ¿AORTIC GROWTH CAN BE OBSERVED IN THE YEARS FOLLOWING IMPLANTATION OF THE AMDS, HENCE IMPLANTATION OF E-NSIDE, E-TEGRA, AND E-LIAC. SINCE THE DISSECTION CONTINUED DISTALLY FROM THE AMDS, A DIRECT CONNECTION BETWEEN THE AMDS AND AORTIC GROWTH CANNOT BE CONFIRMED.¿ NO ADDITIONAL INFORMATION IS FORTHCOMING. UPON COMPLETING A REVIEW OF THE AVAILABLE INFORMATION, GROWTH OF THE AORTIC ARCH IS LIKELY DUE TO ONGOING PERFUSION OF THE FALSE LUMEN AS DESCRIBED BY THE INVESTIGATOR. OF NOTE ¿AORTIC ENLARGEMENT (E.G. PERSISTING FLOW IN THE FALSE LUMEN)¿ IS LISTED IN THE INSTRUCTION FOR USE (IFU) AS A POTENTIAL ADVERSE EVENT. THERE WERE NO REPORTS OF DEVICE MALFUNCTION OR DETERIORATION THAT MAY HAVE LED TO THE EVENT AND THE DEVICE REMAINED IMPLANTED. ARTIVION DEVICE INSPECTION AND LOT HISTORY RECORDS CONFIRMED DEVICE TEST ACCEPTANCE AND APPROVAL. HEALTH IMPACTS AND CLINICAL SIGNS FOR THIS AND OTHER PATIENTS TREATED WITH AMDS WILL CONTINUE TO BE MONITORED TO ENSURE BENEFITS ASSOCIATED WITH THE USE OF THE DEVICE OUTWEIGH THE RISKS. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION- FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THE HDE NUMBER FOR THIS DEVICE - (B)(4). THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION- FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT RECEIVED, PROTECT STUDY PATIENT UNDERWENT POST-OP PROCEDURE ON (B)(6)2023 IN RESPONSE TO EXPERIENCING "NEGATIVE AORTIC REMODELING, AORTIC GROWTH DUE TO FALSE LUMEN PERFUSION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700299 ASCYRUS MEDICAL DISSECTION STENT HYBRID PROSTHESIS HYBRID STENT GRAFT, THORACIC AORTIC LESION TREATMENT QSK ASCYRUS MEDICAL GMBH AMDS UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other