BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3120249 · Received May 20, 2013

    Report

    Report Number
    2024168-2013-03174
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    November 21, 2011
    Report Date
    April 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER CASE REVIEW, AN MDR SHOULD NOT HAVE BEEN FILED AGAINST THE 3.0X33MM RX XIENCE PRIME STENT DELIVERY SYSTEM. THIS INCIDENT WAS INITIALLY CODED IN ERROR, AS THE RX XIENCE PRIME STENT IS NOT INDICATED OR DESIGNED TO SEAL AN ANEURYSM. HOWEVER, SINCE THE INITIAL MDR HAS ALREADY BEEN FILED, THE EVENT MUST REMAIN MDR REPORTABLE. IT SHOULD BE NOTED THAT THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: THE XIENCE PRIME, XIENCE PRIME SV, AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO NATIVE CORONARY ARTERY LESIONS.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW OF THE FOLLOWING PUBLICATION: (CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2013, 81:717-718): EDITORIAL COMMENT: "CORONARY STENT GRAFT: 'A DEVICE IN NEED IS A DEVICE". IT WAS REPORTED THAT ON (B)(6) 2011, A (B)(6) MALE PRESENTED WITH A GIANT CONGENITAL CORONARY ARTERY ANEURYSM IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, AND AN EKG WAS SUGGESTIVE OF AN ANTERIOR WALL MYOCARDIAL INFARCTION. THE PATIENT WAS THROMBOLYZED VIA ADMINISTRATION OF TENECTEPLASE THROMBOLYTIC DRUG. A CORONARY ARTERIOGRAPHY (CART) REVEALED 60% STENOSIS OF THE PROXIMAL LAD WITH A LARGE ANEURYSM IN THAT SEGMENT OF THE LAD. THE PATIENT WAS THEN REFERRED FOR PERCUTANEOUS CORONARY INTERVENTION, WHICH WAS PERFORMED (B)(6) 2011 VIA IMPLANTATION OF A 3.0X33 RX XIENCE PRIME STENT AT THE LESION SITE, EXTENDING WELL BEYOND THE EDGES OF THE ANEURYSM. A 3.5X26 RX JOSTENT GRAFTMASTER COVERED STENT GRAFT WAS THEN IMPLANTED INSIDE OF THE RX XIENCE PRIME. THE JOSTENT GRAFTMASTER WAS POST-DILATED, SUCCESSFULLY TREATING THE ANEURYSM, USING A 4MM NON-COMPLIANT BALLOON AS THE ACTUAL VESSEL SIZE WAS LARGER THAN ORIGINALLY ANTICIPATED. NO ADDITIONAL INFORMATION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221565 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention