BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2964372 · Received February 15, 2013

    Report

    Report Number
    2024168-2013-00923
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 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. CONCOMITANT MEDICAL DEVICES: GUIDE WIRE: SION BLUE; GUIDE CATH: SHEATHLESS 6.5 FR AL1.0, ATLANTIS. THE DEVICE HAS BEEN RETURNED FOR INVESTIGATION. THE INVESTIGATION IS NOT 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 RE-FOLD (FLAT BALLOON) AND RESISTANCE DURING WITHDRAWAL FROM THE GUIDING CATHETER WERE CONFIRMED. 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MILDLY TORTUOUS, CONCENTRIC, MILDLY CALCIFIED, 75% STENOSED, DISTAL RIGHT CORONARY ARTERY (RCA), THE GUIDE WIRE WAS POSITIONED AND THE 3.0 X 8 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND DEPLOYED AT 10 ATMOSPHERE (ATM) FOR 10 SECONDS TWICE; THEN ONCE AT 11 ATM FOR 30 SECONDS. NO ANOMALY WAS NOTED DURING THE INFLATION/DEFLATION. THE SDS WAS REMOVED FROM THE STENT AND THE LESION AREA, HOWEVER, BECAME CAUGHT ON THE GUIDE CATHETER TIP. THE SDS COULD NOT BE FULLY RETRACTED INTO THE GUIDE CATHETER; THE DISTAL MARKER WAS OBSERVED ON ANGIOGRAPHY. THE SDS WAS ADVANCED SLIGHTLY DISTAL AND INFLATED AT LOW PRESSURE, THEN DEFLATED SLOWLY. THE SDS WAS THEN SUCCESSFULLY RETRACTED INTO THE GUIDE CATHETER WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66862 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2091041

    Patients

    Seq Age Sex Outcome Treatment
    1