BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3041655 · Received April 8, 2013

    Report

    Report Number
    2024168-2013-02091
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 14, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED AND THE BALLOON RUPTURE WAS CONFIRMED VIA RETURNED DEVICE ANALYSIS. THE REPORTED PHYSICAL RESISTANCE/DIFFICULTY CROSSING THE LESION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED LOT AND A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE WIRE: RUNTHROUGH NS, RUNTHROUGH EXTRA FLOPPY; GUIDE CATH: MACH1 7F FL4. THE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING AN UNSPECIFIED ACCESS DURING A PROCEDURE OF THE MODERATELY TORTUOUS, MODERATELY CALCIFIED, CONCENTRIC, 99% STENOSED, PROXIMAL CIRCUMFLEX ARTERY, AFTER PRE-DILATATION WITH A 2.0 X 10 MM NON-ABBOTT BALLOON DILATATION CATHETER (BDC), INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED. THE 3.5 X 15 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT MET RESISTANCE WITH THE CALCIFICATION SHORT OF THE LESION BUT IT WAS DELIVERED AND BALLOON INFLATION BEGAN. THE PROXIMAL PORTION OF THE STENT IMPLANT WAS INFLATED AND EXPANDED WHEN THE BALLOON RUPTURED. WHILE ATTEMPTING TO SLOWLY REMOVE THE SDS TOWARD THE GUIDE CATHETER THE STENT IMPLANT DISLODGED IN THE ANATOMY NEAR THE LESION. THE SDS WAS REMOVED. A 1.2 X 6 MM TREK, 2.0 X 8 MM TREK AND A 3.5 MM NC TREK BDCS WERE DELIVERED AND INFLATED INSIDE THE DISLODGED STENT. IVUS WAS USED TO CONFIRM THAT THE STENT COVERED THE TARGET LESION, HOWEVER, ONE OR TWO OF THE PROXIMAL STENT STRUTS WERE PROTRUDING TO THE LEFT MAIN (LM) [OUT OF THE TARGET LESION]. A KISSING BALLOON TECHNIQUE (KBT) WAS PERFORMED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142921 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2083141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CONCOMITANT MEDICAL DEVICES