BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3143385 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03466
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: SION BLUE; GUIDE CATH: MACH1; (B)(4) - RE-INSERTION. 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. PHYSICAL RESISTANCE IN THE LESION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. THE REPORTED SHAFT LEAK WAS CONFIRMED. BASED ON VISUAL 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 STATES: AN UNEXPANDED STENT SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO THE GUIDING CATHETER. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED, AND 100% STENOSED MID RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON AND A 3.0 X 23 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT IT COULD NOT CROSS THE LESION. THE SDS WAS REMOVED AND PRE-DILATATION WAS PERFORMED AT A HIGHER PRESSURE. THE SAME XIENCE PRIME WAS ADVANCED TO THE LESION; HOWEVER, WHEN THE BALLOON WAS PRESSURIZED IT DID NOT INFLATE. THE CATHETER WAS REMOVED FROM THE ANATOMY AND AN ATTEMPT WAS MADE TO INFLATE THE DEVICE WHEN FLUID WAS SEEN LEAKING FROM THE SHAFT AT THE GUIDE WIRE EXIT NOTCH. A NEW XIENCE PRIME WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245336 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2091341

    Patients

    Seq Age Sex Outcome Treatment
    1