BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2870888 · Received December 12, 2012

    Report

    Report Number
    2024168-2012-07878
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 19, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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) - IMPROPER OR INCORRECT PROCEDURE OR METHOD, INCORRECT ANATOMY. XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE: 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. A CINE REVIEW REVEALED THE SURFACE OF THE STENT/VESSEL IS IRREGULAR, LIKELY DUE TO THE INABILITY TO EXPAND THE PLAQUE/FIBROSIS. THE STENT SHADOW (PRE AND POST INJECTION) DOES NOT SUGGEST PRESENCE OF STRUT FRACTURE; HOWEVER, THERE ARE NO IMAGES OF THE POST-DILATATION. IT WAS CONCLUDED THAT THOUGH THE STENT SHADOW IMAGES DO NOT APPEAR STENT/STRUT FRACTURE, IT CANNOT BE RULED OUT. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM 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 DURING AN INTERVENTIONAL PROCEDURE, THE 4.0 X 28 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION SUCCESSFULLY; HOWEVER, THE PHYSICIAN OBSERVED POINTS THOUGHT TO BE STENT FRACTURE SO IT WAS POST DILATED WITH A SEMI COMPLIANT 4.5 X 15 MM BALLOON. THE OBSERVED POINTS OF STENT FRACTURE WERE UNABLE TO BE RESOLVED WITH POSTDILATION AND WERE STILL VISIBLE ON THE FINAL ANGIOGRAM. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1101341

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention