BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3190431 · Received June 26, 2013

    Report

    Report Number
    2024168-2013-03981
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 3, 2013
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE STENT IMPLANT WAS RETURNED FOR EVALUATION. THE STENT DISLODGEMENT WAS CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, CONCENTRIC LESION IN THE DISTAL RIGHT CORONARY ARTERY WITH MILD TORTUOSITY, MILD CALCIFICATION AND 90% STENOSIS. THE VESSEL DIAMETER WAS 3 MM AND THE VESSEL LENGTH WAS 15 MM. PRE-DILATATION WAS PERFORMED WITH AN UNKNOWN BALLOON. A 3.0X18 RX XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE TO THE LESION; HOWEVER, IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. THE SDS WAS WITHDRAWN FROM THE PATIENT ANATOMY AND THE STENT WAS NOTED TO HAVE DISLODGED IN THE AORTA. THE STENT WAS RETRIEVED WITH A SNARE DEVICE. THE TARGET LESION WAS ULTIMATELY TREATED WITH PLAIN OLD BALLOON ANGIOPLASTY WITH AN UNKNOWN BALLOON CATHETER. THERE WAS NO ADVERSE PATIENT SEQUELAE AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. REPORTEDLY, THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE PRIOR TO USE IN THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290856 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3032741

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE WIRE: SIONGUIDE CATH: LAUNCHER 6F AL10