BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3808837 · Received May 13, 2014

    Report

    Report Number
    2024168-2014-03045
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 18, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE WIRE: SION BLUE, HI-TORQUE FLEXI-WIRE; GUIDE CATH: WILDCATH. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE LOT NUMBER WAS REPORTED AS EITHER 3102141 OR 3080941. A REVIEW OF THE LOT HISTORY RECORD FOR BOTH LOTS REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY/REVIEW OF THE ELECTRONIC COMPLAINT DATABASE FOR BOTH LOTS REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR BALLOON RUPTURES. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. FOR LOT #3102141, THE EXPIRATION DATE IS 10/25/2015 AND THE MANUFACTURING DATE IS 10/2013. FOR LOT #3080941, THE EXPIRATION DATE IS 10/25/2015 AND THE MANUFACTURING DATE IS 10/2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, DE NOVO LESION IN THE MID CIRCUMFLEX ARTERY. REPORTEDLY, PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON AND THE 2.25 X 12MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, THE STENT BALLOON RUPTURED DURING FIRST INFLATION AT 5 OR 6 ATMOSPHERES. POST-DILATATION WAS PERFORMED TO THE STENT IMPLANT WITH A NON-ABBOTT BALLOON. A SECOND 2.25 X 12MM XIENCE PRIME WAS DEPLOYED PROXIMAL TO THE FIRST XIENCE PRIME STENT IMPLANT DUE TO THE LONG LESION. THERE WAS NO RESISTANCE DURING PREPARATION, ADVANCEMENT OR REMOVAL OF THE SDS. AFTER THE PROCEDURE, ELEVATION OF CREATINE KINASE LEVEL WAS NOTED, BUT WAS RESOLVED WITHOUT TREATMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286363 XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3102141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CONCOMITANT MEDICAL DEVICES