BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 9490855 · Received December 18, 2019

    Report

    Report Number
    2247858-2019-00080
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    November 14, 2019
    Report Date
    March 2, 2020
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Product Problem
    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 RELAYNBS PLUS THORACIC STENT-GRAFT SYSTEM. THE RELAYNBS PLUS 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 OCCURRED IN GERMANY.

    Description of Event or Problem · 0

    "A RELAY PLUS GRAFT HAS BEEN IMPLANTED AS PLANNED. BY REMOVING THE DELIVERY SYSTEM, THE TIP OF IT CAME OFF BUT THIS WAS NOT RECOGNIZED BY THE PHYSICIANS AT THAT TIME. BY REMOVING THE SYSTEM, THE TIP GOT STUCK ON THE USED PROGLIDE CLOSURE SYSTEM. THEN THE SYSTEM WAS ADVANCED AGAIN AND THEN PULLED BACK INTO THE SHEATH. LATER ON, THE PATIENT EXPERIENCED CLAUDICATION IN THE RIGHT LEG WHEN WALKING. DURING CONTROL DIAGNOSIS, THE TIP WAS FOUND IN THE FEMORAL BIFURCATION ON THE RIGHT SIDE. THE TIP WAS THEN SURGICALLY REMOVED ON THE 19TH NOVEMBER. THE DELIVERY SYSTEM HAS BEEN DISPOSED BUT THE TIP IS AVAILABLE FOR INVESTIGATION AND WILL BE COLLECTED" PATIENT OUTCOME: "PATIENT CONDITION IS GOOD."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    "A RELAY PLUS GRAFT HAS BEEN IMPLANTED AS PLANNED. BY REMOVING THE DELIVERY SYSTEM, THE TIP OF IT CAME OFF BUT THIS WAS NOT RECOGNIZED BY THE PHYSICIANS AT THAT TIME. BY REMOVING THE SYSTEM, THE TIP GOT STUCK ON THE USED PROGLIDE CLOSURE SYSTEM. THEN THE SYSTEM WAS ADVANCED AGAIN AND THEN PULLED BACK INTO THE SHEATH. LATER ON, THE PATIENT EXPERIENCED CLAUDICATION IN THE RIGHT LEG WHEN WALKING. DURING CONTROL DIAGNOSIS, THE TIP WAS FOUND IN THE FEMORAL BIFURCATION ON THE RIGHT SIDE. THE TIP WAS THEN SURGICALLY REMOVED ON THE 19TH NOVEMBER. THE DELIVERY SYSTEM HAS BEEN DISPOSED BUT THE TIP IS AVAILABLE FOR INVESTIGATION AND WILL BE COLLECTED" PATIENT OUTCOME: "PATIENT CONDITION IS GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286540 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B190916016

    Patients

    Seq Age Sex Outcome Treatment
    1 00 YR