BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2902327 · Received January 8, 2013

    Report

    Report Number
    2024168-2013-00154
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 17, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. STENT: XIENCE PRIME 3.0 X 18 AND 3.5 X 18. ASPIRIN. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED STENOSIS AND ISCHEMIA ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT STENTING IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH TWO XIENCE PRIME STENTS (3.0X28, 3.0X18) AND IN THE DISTAL RIGHT CORONARY ARTERY WITH ONE XIENCE PRIME STENT (3.5X18). ON (B)(6) 2012, THE PATIENT HAD A WORSENING OF CORONARY ARTERY DISEASE WITH SILENT ISCHEMIA AND WAS HOSPITALIZED. DIAGNOSTIC CORONARY ANGIOGRAM FOUND A 70% IN-STENT RESTENOSIS IN THE TARGET LESION. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED IN THE MID LAD. THE CONDITION RESOLVED THE SAME DAY. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8988 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 90509P5

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R