BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY THORACIC STENT-GRAFT/PLUS DELIVERY SYST

    MDR report key: 3874136 · Received May 29, 2014

    Report

    Report Number
    2247858-2014-00006
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    October 29, 2013
    Report Date
    May 29, 2014
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR INVOLVES ONE PATIENT THAT WAS IMPLANTED WITH TWO DEVICES. THIS REPORT IDENTIFIED AS "2247858-2014-00006-DEVICE 1" IS FOR THE FIRST DEVICE. THE SEPARATE SECTION REPORT IDENTIFIED AS "2247858-2014-00006- DEVICE 2" IS FOR THE SECOND DEVICE. ADDITIONAL CATALOG#: 28M336145322490U, ADDITIONAL LOT#: 130925180, ADDITIONAL EXPIRATION DATE: 09/25/2016. CONCLUSION: BASED ON THE NARRATIVE, IT DOES NOT APPEAR THAT THE PARALEGIA WAS CAUSED SPECIFICALLY BY BOLTON'S DEVICE, BUT RATHER BY THE NATURE OF THE TEVAR PROCEDURE.

    Description of Event or Problem · 1

    CASE REPORT FROM (B)(6) REPORTED AS: "ON (B)(6) 2013, RELAY 38/34-150 AND RELAY 36/32-150 WERE IMPLANTED IN ZONE2. BOTH OF LOWER LIMBS MOVED A LITTLE IMMEDIATELY AFTER THE PROCEDURE. ON THE NEXT DAY, PARAPLEGIA ON BOTH LOWER LIMBS OF THE PATIENT WAS OBSERVED. ALTHOUGH SPINAL DRAINAGE WAS TRIED, THE DRAINAGE TUBE WAS NOT INSERTED WELL. RIGHT-LEFT AXILLARY ARTERY BYPASS PROCEDURE, FOR IMPROVEMENT OF BLOOD FLOW OF VERTEBRAL ARTERY, DIDN'T HELP. AS OF (B)(6) 2014, THE PATIENT WAS COMPLETE PARAPLEGIA ON HIS BOTH LIMBS. HE IS IN REHABILITATION IN THE REHAB HOSPITAL." DOCTOR'S COMMENT: THE POSSIBLE CAUSES OF PARAPLEGIA WERE THAT BLOOD FLOW OF LEFT VERTEBRAL ARTERY WAS DECREASED BY OCCLUDING SUBCLAVIAN ARTERY WAS DECREASED BY OCCLUDING SUBCLAVIAN ARTERY AND LEFT SUBCLAVIAN ARTERY ROOT WITH THE THORACIC STENT GRAFT AND THE COIL RESPECTIVELY, AND THAT BLOOD FLOW OF OCCLUDED INTERCOSTAL ARTERY WAS INADEQUATE. PARAPLEGIA MAY BE CAUSED BY THE OTHER DEVICE THAN THE RELAY PRODUCTS; THEREFORE, THE RELATION BETWEEN THIS EVENT AND A DEVICE FAILURE ARE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317388 RELAY THORACIC STENT-GRAFT/PLUS DELIVERY SYST STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 130815179

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Disability