BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 8786980 · Received July 12, 2019

    Report

    Report Number
    2247858-2019-00047
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    June 14, 2019
    Report Date
    September 20, 2019
    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 · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE RELAY NBS PLUS THROACIC STENT-GRAFT SYSTEM. THE RELAY NBS PLUS THROACIC STENT-GRAFT SYSTEM 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 RELAY NBS PLUS THROACIC STENT-GRAFT SYSTEM RELATED EVENT OCCURRED IN THAILAND.

    Description of Event or Problem · 0

    "(B)(6) 2017: LCCA-LSCA TRANSLOCATION UNDER RAPID PACING WITH TEVAR AT ZONE 2 (B)(6) 2017: FOLLOW UP REVEAL TINY SMALL ENDOLEAK @ LATERAL ASPECT OF TYPE II OR TYPE III (B)(6) 2017: CTA REVEAL THROMBOSIS ANEURYSM, FOUND AIR COLLECTION AND HEMOPTYSIS. AORTO BRONCHIAL FISTULA (B)(6) 2017: FOLLOW UP REVEAL SMALL TYPE II ENDOLEAK (B)(6) 2018: CTA FOLLOW UP REVEAL TYPE II ENDOLEAK FROM BRACHIAL ARTERY, AORTO BRACHIAL FISTULA SUSPECTED AORTIC STENT. (B)(6) 2018 : S/P LT. THORACOTOMY TO DETECT LUNG AND REPAIR AORTO PULMONARY FISTULA & BOVINE PERICARDIUM (B)(6) 2018 : SLIGHTLY OF TYPE II ENDOLEAK (B)(6) 2019 : CTA FOLLOW UP REVEAL INCREASE SIZE OF ANEURYSMAL SAC FROM 6.0*5.0 TO 7.1*6.5 CM" PATIENT OUTCOME: (B)(6) 2019: RE-DO TEVAR FOUND TYPE III ENDOLEAK FROM AORTIC STENT AS THE FLUOROSCOPY'S IMAGE FROM THE OPERATIVE."

    Additional Manufacturer Narrative · 1

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE RELAY NBS PLUS THORACIC STENT-GRAFT SYSTEM. THE RELAY NBS PLUS THORACIC STENT-GRAFT SYSTEM 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 RELAY NBS PLUS THORACIC STENT-GRAFT SYSTEM RELATED EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    "ON (B)(6) 2017: LCCA-LSCA TRANSLOCATION UNDER RAPID PACING WITH TEVAR AT ZONE 2. ON (B)(6) 2017: FOLLOW UP REVEAL TINY SMALL ENDOLEAK @ LATERAL ASPECT OF TYPE II OR TYPE III. ON (B)(6) 2017: CTA REVEAL THROMBOSIS ANEURYSM, FOUND AIR COLLECTION AND HEMOPTYSIS. AORTO BRONCHIAL FISTULA. ON (B)(6) 2017: FOLLOW UP REVEAL SMALL TYPE II ENDOLEAK. ON (B)(6) 2018: CTA FOLLOW UP REVEAL TYPE II ENDOLEAK FROM BRACHIAL ARTERY, AORTO BRACHIAL FISTULA SUSPECTED AORTIC STENT. ON (B)(6) 2018: S/P LT. THORACOTOMY TO DETECT LUNG AND REPAIR AORTO PULMONARY FISTULA & BOVINE PERICARDIUM. ON (B)(6) 2018: SLIGHTLY OF TYPE II ENDOLEAK. ON (B)(6) 2019: CTA FOLLOW UP REVEAL INCREASE SIZE OF ANEURYSMAL SAC FROM 6.0*5.0 TO 7.1*6.5 CM." PATIENT OUTCOME: (B)(6) 2019: RE-DO TEVAR FOUND TYPE III ENDOLEAK FROM AORTIC STENT AS THE FLUOROSCOPY'S IMAGE FROM THE OPERATIVE IN ATTACHED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581032 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B170103026

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R