BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1518392 · Received October 23, 2009

    Report

    Report Number
    2024168-2009-01942
    Event Type
    Malfunction
    Date Received
    October 23, 2009
    Date of Event
    September 30, 2009
    Report Date
    September 30, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). THE 2.75 X 12 MM XIENCE V (PART 1009528-12, LOT 8082841), INDICATED IS BEING FILED UNDER MFR#2021468-2009-01940. THE 2.75 X 18MM XIENCE V (PART 1009528-18, LOT 9021961), INDICATED IS BEING FILED UNDER MFR#2021468-2009-01941.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: SHAFT SEPARATION HAS CAUSED OR CONTRIBUTED TO PT INJURY PREVIOUSLY. DEVICE ISSUE: SHAFT SEPARATION. IT WAS REPORTED THAT THE TARGET LESION WAS THE CX AND THE PROXIMAL PART OF THE VESSEL WAS ANGULATED. THE LESION WAS WIRED AND DILATED WITH A 3.0 X 20 MM VOYAGER BALLOON WITH DIFFICULTY. AN ATTEMPT WAS MADE TO STENT THE VESSEL WITH THREE DIFFERENT STENTS, A 2.75 X 12 MM XIENCE V, A 2.75 X 18 MM XIENCE V AND A 2.75 X 15 MM PROMUS. AS THE PROXIMAL VESSEL WAS ANGULATED IT WAS HARD TO GET THE STENT DELIVERY SYSTEMS (SDS) DOWN REQUIRING FORCE TO BE APPLIED, AND THE SHAFTS OF ALL THREE SDS SEPARATED. THE LESION WAS EVENTUALLY ABANDONED FOR STENTING. A CINE CD OF THE PROCEDURE IS BEING RETURNED. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8112741

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STENT: 2.75 X 12 MM XIENCE V| (PART 1009528-12, LOT 8082841)| 2.75 X 18 MM XIENCE V(PART 1009528-18,LOT 9021961)| DILATATION CATHETER: 3.0 X 20 MM VOYAGER