BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT GUIDEWIRE

    MDR report key: 2338393 · Received November 7, 2011

    Report

    Report Number
    2338393
    Event Type
    Malfunction
    Date Received
    November 7, 2011
    Date of Event
    October 23, 2011
    Report Date
    November 7, 2011
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH AN ACUTE INFERIOR WALL INFARCTION AND PATIENT WAS TAKEN TO THE CARDIAC CATH LAB FOR CORONARY ANGIOGRAM AND STENT PROCEDURE. THE RIGHT CORONARY ARTERY (RCA) HAS MILD DIFFUSE LUMINAL IRREGULARITIES. THERE WAS 90% STENOSIS IN THE RIGHT POSTERIOLATERAL (RPL). THE LESION WAS DESCRIBED AS SINGLE DISCRETE PROXIMAL. THERE WAS 100% STENOSIS IN THE 1ST RPL. THE LESION WAS 10 MM LONG AND 3 MM IN DIAMETER. THE LESION WAS DESCRIBED AS SINGLE DISCRETE, OSTIAL. AN INITIAL 2.75 MM X 15 MM PROMUS DES LOT # 1050661 RED # 1009540-15B) WAS PLACED SUCCESSFULLY ACROSS THE RIGHT POSTERIOLATERAL 1 BRANCH. THE LESION WAS CROSSED WITH A GUIDEWIRE (SEE DEVICE #). AN INTERVENTION WAS PERFORMED ON THE 1ST RPL WHICH WAS A SUCCESS WITH A FINAL STENOSIS OF 0%. THERE WERE NO LESION COMPLICATIONS. THE FINAL T1M1 FLOW WAS 3. HOWEVER, UPON WITHDRAWAL OF THE GUIDEWIRE, THE WIRE TIP BECAME ENTRAPPED IN THE STENT. IN ATTEMPTING TO WITHDRAW THE GUIDEWIRE, THE TIP FRACTURED AND THE STENT APPEARED TO BE DEFORMED. THE DISTAL TIP REMAINS IN THE DISTAL RCA. TIP WAS NOTED ON X-RAY. A SECOND GUIDEWIRE WAS PASSED ACROSS THIS SEGMENT AND A SECOND 3.0 MM X 18 MM PROMUS DES WAS DEPLOYED IN AN ATTEMPT TO CRUSH THE INITIAL STENT AND ENTRAPPED GUIDEWIRE ALONG THE WALL. THE CARDIOLOGIST RECOMMENDED DEFERRING PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RIGHT POSTERIOR DESCENDING ARTERY (RPDA) FOR AT LEAST 6 TO 8 WEEKS. THE PATIENT WAS DISCHARGED HOME IN GOOD CONDITION ON POST-PROCEDURE DAY #2, WITH A PLANNED PCI OF THE RPDA IN 6-8 WEEKS. THE PATIENT WILL RESUME NORMAL ACTIVITY AS TOLERATED AND CARDIAC REHABILITATION WAS RECOMMENDED.======================MANUFACTURER RESPONSE FOR CARDIAC STENT GUIDEWIRE, HI-TORQUE BALANCE MIDDLEWEIGHT GUIDEWIRE (PER SITE REPORTER).======================CALLED THE ABBOTT VASCULAR TERRITORY MANAGER 11/07/2011. DEVICE WILL BE RETURNED TO ABBOTT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT GUIDEWIRE CARDIAC STENT GUIDEWIRE DQX ABBOTT VASCULAR REF 1001780-HC 1040171

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR