BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3183198 · Received June 21, 2013

    Report

    Report Number
    2024168-2013-03894
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FAILURE TO FOLLOW STEPS/INSTRUCTION AND INDICATION FOR USE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. DIFFICULT TO DEPLOY/PARTIAL APPOSITION AND DIFFICULTY/RESISTANCE REMOVING THE DEVICE FROM THE ANATOMY COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS THEY WERE BASED ON OPERATIONAL CIRCUMSTANCES. BALLOON LEAK/RUPTURE AND SHAFT SEPARATION WERE CONFIRMED. 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. IT SHOULD BE NOTED THAT THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: XIENCE PRIME IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO (NEW) NATIVE CORONARY ARTERY LESIONS. IT SHOULD BE NOTED THAT THE IFU STATES: STENT PLACEMENT SHOULD ONLY BE PERFORMED AT HOSPITALS WHERE EMERGENCY CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY CAN BE READILY PERFORMED. BASED ON THE AVAILABLE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A RADIAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE RESTENOSED, MID RIGHT CORONARY ARTERY (RCA) PREDILATATION WAS PERFORMED WITH A UNSPECIFIED BALLOON DILATATION CATHETER (BDC). THE 3.5 X 23 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND DELIVERED AT THE LESION. THE SDS BALLOON WAS INFLATED; HOWEVER, THE PRESSURE SUDDENLY FAILED AS IF THE BALLOON HAD RUPTURED. SEVERAL ATTEMPTS TO REMOVE THE BALLOON WERE UNSUCCESSFUL. THE BALLOON REMAINED IN THE PARTIALLY OPENED STENT. DURING THE ATTEMPTS TO DISLODGE AND REMOVE THE BALLOON FROM THE STENT, THE SDS SHAFT SEPARATED. THE PARTIALLY EXPANDED STENT REMAINED IN THE ARTERY AND THE DISTAL CATHETER FRAGMENT WAS CAUGHT INSIDE; THE PROXIMAL PART OF THE FRAGMENT WAS FLOATING IN THE AORTA. SEVERAL ATTEMPTS WERE MADE UNSUCCESSFULLY TO RETRIEVE THE FRAGMENT. A DIFFERENT BDC WAS ADVANCED TO COMPRESS THE FRAGMENT TO THE ARTERY WALL WITHOUT SUCCESS. THE PATIENT WAS TRANSFERRED TO THE SURGICAL CENTER OF A SECOND HOSPITAL WHERE THE INTERVENTIONAL CARDIOLOGIST ATTEMPTED TO EXPAND THE STENT AND RETRIEVE THE BALLOON FRAGMENT WITHOUT SUCCESS. A SURGICAL PROCEDURE FOR CORONARY ARTERY BYPASS GRAFTING (CABG) WAS PERFORMED AND THE BALLOON FRAGMENT WAS EXTRACTED THE SAME NIGHT. IT WAS NOTED THAT THE FRAGMENT WAS APPROXIMATELY 35 CM IN LENGTH. THE PATIENT REMAINS HOSPITALIZED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283021 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2051741

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R| S