BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2834527 · Received November 15, 2012

    Report

    Report Number
    2024168-2012-07234
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 23, 2012
    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. RX XIENCE PRIME LL 3.5 X 33 MM AND RX XIENCE V 3.0 X 28 MM. THE RX XIENCE PRIME LL 3.5 X 33 MM AND RX XIENCE V 3.0 X 28 MM ARE BEING FILED UNDER SEPARATE MANUFACTURER REPORT NUMBERS. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: DATE OF EVENT, CORRECTION: THERAPY DATE. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD 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. A REVIEW OF RECEIVED CINE IMAGES CONCLUDED THAT THE IMAGES ARE CONSISTENT WITH STENT FRACTURE AND RESTENOSIS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE PERCUTANEOUS TRANSLUMINAL INTERVENTION (B)(6) 2011, IN WHICH A 3.5X33 RX XIENCE PRIME STENT WAS IMPLANTED IN THE MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, A 3.0X28 XIENCE V RX STENT WAS IMPLANTED IN THE HEAVILY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA), AND A 3.0X33 RX XIENCE PRIME WAS IMPLANTED IN THE HEAVILY TORTUOUS MID RCA, OVERLAPPING THE STENT PLACED IN THE DISTAL RCA. THE PATIENT PRESENTED WITH ANGINA (B)(6) 2012 AND WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL. AN ANGIOGRAM REVEALED RESTENOSIS IN ALL THREE STENTS IMPLANTED IN THE LAD AND RCA VESSELS. THE TWO STENTS IMPLANTED IN THE RCA APPEARED TO BE FRACTURED IN FOUR DIFFERENT PLACES; HOWEVER, NOT SEPARATED. MEDICATION WAS ADMINISTERED AND THE PHYSICIAN HAS RECOMMENDED SURGERY; AS OF (B)(6) 2012, NO SURGERY HAS BEEN PERFORMED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR BEING FILED, THE DATE OF OCCURRENCE WAS CLARIFIED TO BE (B)(4) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0063041

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R