BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 10491093 · Received September 3, 2020

    Report

    Report Number
    2247858-2020-00039
    Event Type
    Injury
    Date Received
    September 3, 2020
    Date of Event
    May 12, 2020
    Report Date
    September 3, 2020
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE RELAYPLUS SCALLOP CUSTOM-MADE DEVICE. THE RELAYPLUS SCALLOP CUSTOM-MADE DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US IN 2012 (P110038). THE RELAYPLUS SCALLOP CUSTOM-MADE DEVICE RELATED EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    "PATIENT RECEIVED TWO CM THORACIC STENT-GRAFTS TO EXCLUDE THE THORACIC ANEURYSM. TWO-STAGED PROCEDURE. FIRST IMPLANTATION (B)(6) 2020 ((B)(4)), SECOND (B)(6) 2020 ((B)(4)), REF 28NC38N22536N2590, LOT 2006260086. AFTER IMPLANTATION OF THE SECOND GRAFT A POST CT SCAN WAS PERFORMED. HERE AN ENDOLEAK TYP III B WAS DETECTED. THE ENDOLEAK WAS REPAIRED WITH A RELAYPLUS 36X100." PATIENT OUTCOME: "PATIENT RECEIVED A THIRD PROCEDURE. ENDOLEAK IS CLOSED. PATIENT IS FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956465 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2004290100

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other| R