BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2853388 · Received November 30, 2012

    Report

    Report Number
    2024168-2012-07600
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 7, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE PROXIMAL SHAFT OF THE DEVICE WAS SEPARATED. THE REPORTED INFLATION ISSUE COULD NOT BE REPLICATED DUE TO THE CONDITION OF THE RETURNED DEVICE. ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT THE SEPARATION RESULTED FROM POST-PROCEDURAL HANDLING. BASED ON 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 COULD 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 EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    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 REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED, AND 99% STENOSED PROXIMAL CIRCUMFLEX ARTERY. PRE-DILATATION WAS PERFORMED WITH A 2.5 X 12 MM SEMI COMPLIANT BALLOON INFLATED TO 9 ATMOSPHERES. A 3.5 X 23 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION; HOWEVER, THE BALLOON WOULD NOT INFLATE. THE SDS WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.5 X 23 MM XIENCE V. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. 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 2052841

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR