BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2103735 · Received May 26, 2011

    Report

    Report Number
    2024168-2011-03725
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED XIENCE V STENT DELIVERY SYSTEM (SDS) NOTED CONTRAST VISIBLE ON THE SHAFT, CONSISTENT WITH HANDLING. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THE YELLOW PROTECTIVE SHEATH WAS RETURNED ON THE STENT IMPLANT. THE STYLET WAS RETURNED ADVANCED THROUGH THE TIP AND GUIDE WIRE LUMEN. THERE WAS A KINK IN THE SHAFT DISTAL TO THE STRAIN RELIEF TUBING. THE REPORTED DIFFICULTY COULD NOT BE CONFIRMED AS AN INDEFLATOR, FILLED WITH WATER, WAS USED TO PREPARE THE SDS WITH NO AIR BUBBLES OR LEAK NOTED. THE BALLOON WAS INFLATED TO THE RATED BURST PRESSURE (RBP) WITH NO DAMAGE OR LEAK NOTED. IT IS POSSIBLE THERE WAS A FAULTY CONNECTION BETWEEN THE SDS AND THE INFLATION DEVICE; HOWEVER, THIS COULD NOT BE CONFIRMED. FURTHER, AS THE NOTED KINK IN THE SHAFT DID NOT APPEAR TO CONTRIBUTE TO THE DIFFICULTY, THE DAMAGE MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR LEAKS FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE PREPARATION, A LEAK IN THE BALLOON WAS DETECTED. THERE WAS NO PATIENT INVOLVEMENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 9100661

    Patients

    Seq Age Sex Outcome Treatment
    1