BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3112484 · Received May 14, 2013

    Report

    Report Number
    2024168-2013-03045
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. (B)(4): NO PRE-DILATATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE DEFLATION ISSUE WAS NOT CONFIRMED. THE RESISTANCE DURING WITHDRAWAL COULD NOT BE REPLICATED DUE TO THE CONDITION OF THE RETURNED DEVICE. BASED ON VISUAL, FUNCTIONAL, AND DIMENSIONAL 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE (B)(4)XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE STATES: PRE-DILATE THE LESION WITH A PTCA CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE RIGHT CORONARY ARTERY, DIRECT STENTING WAS PERFORMED USING A 3.5X18 RX XIENCE PRIME STENT DELIVERY SYSTEM. DURING STENT DEPLOYMENT, THE STENT SYSTEM BALLOON WAS INFLATED TO 12 ATMOSPHERES AND THE STENT WAS SUCCESSFULLY DEPLOYED. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON; HOWEVER, THE BALLOON REMAINED PARTIALLY INFLATED. AN ATTEMPT WAS MADE TO PULL THE STENT DELIVERY SYSTEM INTO THE 6F GUIDE CATHETER. APPROXIMATELY 3/4 OF THE BALLOON WAS PULLED INTO THE GUIDE CATHETER WITH THE REMAINING PORTION OF THE BALLOON OUTSIDE OF THE GUIDE CATHETER; THEREFORE, THE GUIDE CATHETER AND THE STENT DELIVERY SYSTEM WERE WITHDRAWN FROM THE ANATOMY AS A SINGLE UNIT. OUTSIDE OF THE ANATOMY, CONTRAST WAS OBSERVED IN THE BALLOON. AN UNSUCCESSFUL ATTEMPT WAS MADE TO PULL NEGATIVE PRESSURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213617 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3012141

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER: 6F IKARI (TERUMO)