BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3900332 · Received June 27, 2014

    Report

    Report Number
    2024168-2014-04170
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    April 5, 2014
    Report Date
    June 3, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE KNOWN OBSERVED AND POTENTIAL PATIENT EFFECTS AS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU). A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY/REVIEW OF THE ELECTRONIC COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL REPORT FILING, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT ON (B)(6) 2014 DUE TO A NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI), THE 3.0X33MM XIENCE PRIME STENT IMPLANT WAS SUCCESSFULLY DEPLOYED TO TREAT AN 85% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WERE NO REPORTED DEVICE OR PROCEDURE ISSUES DURING THE INDEX PROCEDURE. IT WAS CONFIRMED THAT THE PATIENT HAD BEEN COMPLIANT WITH DUAL ANTIPLATELET DRUG THERAPY (DAPT). ON (B)(6) 2014, THE PATIENT PRESENTED WITH AN ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) AND INTRAVASCULAR ULTRASOUND (IVUS) NOTED STENT FRACTURE AND THROMBOSIS OF THE DEPLOYED XIENCE PRIME STENT IMPLANT. REPORTEDLY, THE STENT FRACTURE MAY HAVE OCCURRED DUE TO THE MID-PORTION OF THE STENT IMPLANT FLEXING WITH HEART MOVEMENT. THE STENT FRACTURE AND THROMBOSIS WERE TREATED WITH BALLOON ANGIOPLASTY AND DEPLOYMENT OF A 3.0X8MM XIENCE STENT AND A 3.0X18MM XIENCE STENT. THE PATIENT ALSO EXPERIENCED HEART FAILURE AND IS ON CONGESTIVE HEART FAILURE (CHF) MEDICATION AND IS REPORTED TO BE IMPROVING. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH AN IMPLANTED 3.0 X 33 MM XIENCE PRIME STENT EXPERIENCED STENT THROMBOSIS. THE IMPLANTED STENT WAS VIEWED UNDER INTRA-VASCULAR ULTRA SOUND (IVUS), AND IT APPEARED TO HAVE A GAP IN IT, SUGGESTING A STENT FRACTURE. BALLOONING WAS PERFORMED AT HIGH PRESSURE WITH A 3.0 MM NC TREK BALLOON. NO ADVERSE PATIENT SEQUELA WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376846 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3070841

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S