BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4144971 · Received October 6, 2014

    Report

    Report Number
    2024168-2014-06466
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE DAMAGED BY ANOTHER DEVICE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL INSPECTION 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. A QUERY/REVIEW OF THE COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR DEVICE DAMAGE BY ANOTHER DEVICE FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE REPORTED PATIENT EFFECTS OF DISSECTION AND OCCLUSION, AS LISTED IN THE XIENCE PRIME LONG LENGTH (LL) EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH THE USE OF CORONARY STENTS. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: ASAHI SION; BALANCE MIDDLEWEIGHT UNIVERSAL II. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MODERATELY CALCIFIED, DE NOVO, OSTIAL PROXIMAL RIGHT CORONARY ARTERY (RCA) AFTER DIAGNOSTIC ANGIOGRAPHY THE BALANCE MIDDLEWEIGHT UNIVERSAL II (BMWII) GUIDE WIRE AND THE ASAHI SION GUIDE WIRE FOR SUPPORT WERE POSITIONED. A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION. A 3.0 X 33 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED IN THE GUIDE CATHETER; HOWEVER, THE GUIDE WIRE AND THE SDS LOST POSITION AT THE LESION WHEN THE GUIDE CATHETER WAS DEEP SEATED AND BOTH A VESSEL DISSECTION AND A VESSEL OCCLUSION WERE NOTED. THE SDS WAS REMOVED AND REPLACED WITH TWO SHORTER SDSS; TOGETHER WITH THE GUIDE WIRE THE VESSEL WAS TREATED WITHOUT REPORTED ISSUE. IT WAS NOTED BY THE PHYSICIAN THAT THE PRESSURE HAD BEEN RAPIDLY INCREASED RESULTING IN THE ACUTE VESSEL CLOSURE AND PRIOR DEVICE DISPLACEMENT. THE VESSEL WAS POST-DILATATED USING A 3.0 X 15 MM NC TREK BDC. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. 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
    624273 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3073142

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention