BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2760877 · Received September 26, 2012

    Report

    Report Number
    2024168-2012-06068
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 2, 2012
    Report Date
    September 3, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DLL: GUIDE WIRE: JOKER, EEL LIGHT, GUIDE CATH: TAIGA SAL1. (B)(4) - NO PRE-DILATATION AND RE-INSERTION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THE XIENCE V INSTRUCTIONS FOR USE (IFU) STATES: AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. AN UNEXPANDED STENT SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO THE GUIDING CATHETER. [SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED AS THE STENT MAY BE DAMAGED OR / AND DISLODGED FROM THE BALLOON WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER.] THE IFU ALSO STATES: PRE-DILATE THE LESION WITH A PTCA CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL / LESION TO BE TREATED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ACUTE MYOCARDIAL INFARCT CASE. THE LESION WAS A HEAVILY TORTUOUS, HEAVILY CALCIFIED, CONCENTRIC, AND 90% STENOSED PROXIMAL LEFT CIRCUMFLEX. THE VESSEL DIAMETER WAS 3.0MM AND THE LESION LENGTH WAS 20MM. A NON-ABBOTT GUIDE WIRE WOULD NOT CROSS THE LESION SO IT WAS EXCHANGED FOR A DIFFERENT NON-ABBOTT GUIDE WIRE WHICH CROSSED. A 3.0 X 28 MM XIENCE V WAS ADVANCED; HOWEVER, IT WOULD NOT CROSS THE LESION. A 2.5 X 15 MM NC TREK WAS THEN USED FOR PRE-DILATATION AND THE XIENCE V WAS ABLE TO CROSS. THE BALLOON RUPTURED AT 14 ATMOSPHERES AT THE SECOND INFLATION. POST-DILATATION WAS PERFORMED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1100441

    Patients

    Seq Age Sex Outcome Treatment
    1