BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 10801081 · Received November 6, 2020

    Report

    Report Number
    2247858-2020-00055
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    October 9, 2020
    Report Date
    December 30, 2020
    Manufacturer
    BOLTON MEDICAL
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE RELAYNBS PLUS THORACIC STENT-GRAFT SYSTEM. THE RELAYNBS PLUS 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 RELAYNBS PLUS RELATED EVENT OCCURED IN CHINA.

    Description of Event or Problem · 0

    THE PATIENT HAD A CHRONIC INTERCALATION WITH THROMBOSIS IN THE INTERCALATION WITHIN ONE MONTH OF ONSET. FEMORAL ARTERY PUNCTURE WAS USED FOR THE APPROACH (ABBOTT, PROGLIDE) AND RELAY NBS PLUS DELIVERY SYSTEM INSERTED SUCCESSFULLY AND THE STENT- GRAFT HAD RELEASED WITHOUT DIFFICULTY. HOWEVER, IT WAS DIFFICULT FOR THE DELIVERY SYSTEM TO WITHDRAW AT THE FEMORAL ARTERY ENTRY, AND IT WAS SUSPECTED THAT THE CONICAL TIP HEAD WAS HOOKED BY THE SUTURE OF PROGLIDE. AFTER SEVERAL ADJUSTMENTS, THE WHOLE DELIVERY SYSTEM WAS WITHDRAWN FINALLY WITHOUT DAMAGE. THE SURGEON FOUND IN VITRO THAT THE TAPERED TIP ACTUALLY FAILED TO FULLY RECOVER THE OUTER SHEATH, AND THERE WERE SMALL CRACKS AT THE BOTTOM OF THE TAPERED TIP HEAD (WHICH SHOULD BE CAUSED BY THE CUT OF THE OUTER SHEATH). WHEN TOUCHING THE TAPERED TIP OF THE DELIVERY SYSTEM, THE TAPERED TIP SPLIT AWAY OFF THE INNER STEEL OF THE DELIVERY SYSTEM. THE SURGEON SUSPECTED THERE WAS A QUALITY PROBLEM WITH THE RELAY NBS PLUS. PATIENT OUTCOME: "NO PATIENT INJURY".

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT HAD A CHRONIC INTERCALATION WITH THROMBOSIS IN THE INTERCALATION WITHIN ONE MONTH OF ONSET. FEMORAL ARTERY PUNCTURE WAS USED FOR THE APPROACH (ABBOTT, PROGLIDE) AND RELAY NBS PLUS DELIVERY SYSTEM INSERTED SUCCESSFULLY AND THE STENT- GRAFT HAD RELEASED WITHOUT DIFFICULTY. HOWEVER, IT WAS DIFFICULT FOR THE DELIVERY SYSTEM TO WITHDRAW AT THE FEMORAL ARTERY ENTRY, AND IT WAS SUSPECTED THAT THE CONICAL TIP HEAD WAS HOOKED BY THE SUTURE OF PROGLIDE. AFTER SEVERAL ADJUSTMENTS, THE WHOLE DELIVERY SYSTEM WAS WITHDRAWN FINALLY WITHOUT DAMAGE. THE SURGEON FOUND IN VITRO THAT THE TAPERED TIP ACTUALLY FAILED TO FULLY RECOVER THE OUTER SHEATH, AND THERE WERE SMALL CRACKS AT THE BOTTOM OF THE TAPERED TIP HEAD (WHICH SHOULD BE CAUSED BY THE CUT OF THE OUTER SHEATH). WHEN TOUCHING THE TAPERED TIP OF THE DELIVERY SYSTEM, THE TAPERED TIP SPLIT AWAY OFF THE INNER STEEL OF THE DELIVERY SYSTEM. THE SURGEON SUSPECTED THERE WAS A QUALITY PROBLEM WITH THE RELAY NBS PLUS. PATIENT OUTCOME: "NO PATIENT INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262615 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL B200611275

    Patients

    Seq Age Sex Outcome Treatment
    1 00 YR