BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3128273 · Received May 23, 2013

    Report

    Report Number
    2024168-2013-03254
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: ROUTE; GUIDE CATH: GADELIUS NX-R 4.0. (B)(4) - ABOVE RATED BURST PRESSURE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. BALLOON LEAK/RUPTURE AND SHAFT SEPARATION WERE CONFIRMED. DIFFICULT TO REMOVE POST-DEPLOYMENT COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL, FUNCTIONAL, AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING 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 AVAILABLE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. REPORTEDLY, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION. ALTHOUGH A CONCLUSIVE CAUSE FOR THE PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE IF ANY CANNOT BE DETERMINED, VENTRICULAR FIBRILLATION IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. IT SHOULD BE NOTED THAT THE JAPAN XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM IFU STATES: DO NOT EXCEED THE LABELED RATED BURST PRESSURE (RBP). IT SHOULD BE ALSO NOTED THAT THE IFU STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST-STENT IMPLANTATION, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND 90% STENOSIS. A NON-ABBOTT GUIDE WIRE WAS CROSSED AND INTRA-VASCULAR ULTRA SOUND (IVUS) WAS PERFORMED. PRE-DILATATION WAS PERFORMED WITH A 2.5 X 15 MM NON-ABBOTT BALLOON AT 6 ATMOSPHERES (ATM) FOR 15 SECONDS AND 12 ATM FOR 20 SECONDS. THE 3.5 X 15 MM XIENCE PRIME STENT WAS IMPLANTED, HOWEVER THE STENT DELIVERY SYSTEM (SDS) BALLOON RUPTURED AT 19 ATM DURING INFLATION. AN ATTEMPT WAS MADE TO RETRACT THE SDS; HOWEVER, RESISTANCE WAS FELT WITH THE IMPLANTED STENT. THE SDS BALLOON WAS INFLATED AND DEFLATED AGAIN AND THE DEVICE WAS RETRACTED UNDER RESISTANCE. SUBSEQUENTLY THE DISTAL PART OF THE DEVICE WITH THE SDS BALLOON SEPARATED. THE PHYSICIAN COMMENTED THAT THE SEPARATED PORTION LIKELY REMAINED IN THE PROXIMAL RCA INSIDE THE IMPLANTED STENT. THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION AND WAS TREATED WITH DIRECT CURRENT CARDIOVERSION. THE PATIENT WAS TRANSFERRED TO THE CRITICAL CARE UNIT (CCU) IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230068 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2100241

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R