BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3110137 · Received May 13, 2013

    Report

    Report Number
    2024168-2013-03022
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. THE 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. THE REPORTED WINGED BALLOON WAS CONFIRMED AS THE BALLOON WAS RETURNED FLAT. THE REPORTED RESISTANCE DURING WITHDRAWAL FROM THE GUIDING CATHETER WAS NOT CONFIRMED. BASED ON VISUAL AND FUNCTIONAL 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIENCE XPEDITION WAS DEPLOYED IN THE MODERATELY CALCIFIED, MILDLY TORTUOUS, MID RIGHT CORONARY ARTERY (RCA) AT 17 ATMOSPHERES FOR 13 SECONDS WITHOUT ISSUE. THE PHYSICIAN COMMENTED THAT THE DELIVERABILITY WAS VERY GOOD; HOWEVER, THERE WAS SOME RESISTANCE ENCOUNTERED DURING REMOVAL OF THE STENT DELIVERY SYSTEM (SDS) AFTER DEPLOYMENT. THE SDS WAS ONLY INFLATED ONE TIME. THE STENT APPEARED WELL APPOSED AND THE PHYSICIAN WAS SATISFIED WITH THE RESULTS. AFTER DEPLOYMENT, NEGATIVE PRESSURE WAS APPLIED, FOLLOWED BY NEUTRAL, THEN BACK TO NEGATIVE PRESSURE. THE PHYSICIAN WAITED APPROXIMATELY TEN TO TWELVE SECONDS FOR THE SDS TO DEFLATE PRIOR TO HIS WITHDRAWAL OF THE DEVICE FROM THE ANATOMY. THE PHYSICIAN'S WORDS WERE, 'THE GUIDE SUCKED IN.' THE SDS BALLOON APPEARED WINGED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210978 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2110541

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR GUIDE WIRE: RUNTHROUGH, GUIDE CATH: 6 FRENCH KR4H