BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2895336 · Received January 3, 2013

    Report

    Report Number
    2024168-2013-00032
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: BMW UNIVERSAL II, FIELDER, GUIDE CATH: HEARTRAIL II 6F JL3.5, VIEWIT. (B)(4) - NO PREDILATATION. 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 RUPTURE WAS CONFIRMED. BASED ON VISUAL, FUNCTIONAL, AND SCANNING ELECTRON MICROSCOPY 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 JAPAN XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE STATES: PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH MILD TORTUOSITY. THE 2.75 X 15 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION FOR DIRECT-STENTING. SOME RESISTANCE WAS NOTED DURING CROSSING OF THE LESION DUE TO THE TORTUOSITY. THE STENT WAS DEPLOYED AT AN UNKNOWN PRESSURE AND THE SDS WAS REMOVED. THE PHYSICIAN GENTLY TRIED TO MAKE THE BALLOON ITS ORIGINAL SHAPE BY HAND, AND ATTEMPTED TO DELIVER THE SDS BALLOON TOWARD THE LESION FOR POST-DILATATION; HOWEVER, DURING ADVANCEMENT INSIDE THE GUIDING CATHETER, BLOOD CAME INTO THE INFLATION LUMEN. THE SDS WAS REMOVED AND A PINHOLE RUPTURE WAS FOUND ON THE BALLOON. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2635 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2053141

    Patients

    Seq Age Sex Outcome Treatment
    1