BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3092406 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02758
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 7, 2013
    Report Date
    April 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. FAILURE TO ADVANCE/CROSS THE LESION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. DIFFICULT TO REMOVE/GUIDING CATHETER RESISTANCE AND STENT MOVEMENT WERE NOT CONFIRMED. BASED ON VISUAL, DIMENSIONAL, AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE INSTRUCTS THE PHYSICIAN TO PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED, AND 90% STENOSED DISTAL CIRCUMFLEX ARTERY. A 2.5 X 28 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED TO THE LESION: HOWEVER, THE STENT CAUGHT ON THE SIDE HOLE OF THE GUIDING CATHETER AND THE STENT MOVED ON THE BALLOON. THE DEVICE WAS REMOVED AND PRE-DILATATION WAS PERFORMED WITH AN UNKNOWN 2.0 X 20 MM BALLOON CATHETER. A SECOND 2.5 X 28 MM XIENCE PRIME SDS WAS ADVANCED AND THERE WAS STILL RESISTANCE AND THE DEVICE COULD NOT CROSS THE LESION. THE SDS WAS REMOVED AND A 2.5 X 20 MM BALLOON CATHETER WAS USED FOR PRE-DILATATION. THE SAME XIENCE PRIME WAS ADVANCED TO THE LESION AND SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE TOOK OVER AN HOUR TO COMPLETE; HOWEVER, THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194830 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2112941

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR