BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2851524 · Received November 29, 2012

    Report

    Report Number
    2024168-2012-07558
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 6, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    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. DATE OF EVENT ESTIMATED. DATE OF IMPLANT ESTIMATED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING, THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT ALSO COULD NOT BE CONDUCTED BECAUSE THE LOT IDENTIFICATION NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON REVIEW OF THE ABSTRACT, SERIAL CHANGES OF EVEROLIMUS-ELUTING STENT MAL-APPOSITION: AN OPTICAL COHERENCE TOMOGRAPHY SUB-ANALYSIS FROM THE RESET TRIAL. BACKGROUND: THE LONG TERM OUTCOME OF STENT MAL-APPOSITION AFTER STENT IMPLANTATION REMAINS UNCLEAR. THE AIM OF THIS STUDY WAS TO EVALUATE SERIAL CHANGES OF STENT MAL-APPOSITION AFTER EVEROLIMUS-ELUTING STENT IMPLANTATION BY USING OPTICAL COHERENCE TOMOGRAPHY (OCT). METHODS: RANDOMIZED EVALUATION OF SIROLIMUS-ELUTING VERSUS EVEROLIMUS-ELUTING STENT TRIAL (RESET) WAS A PROSPECTIVE DUAL-ARM RANDOMIZED TRIAL OF EVEROLIMUS-ELUTING STENTS AND SIROLIMUS-ELUTING STENTS IN 3200 PATIENTS WITH CORONARY ARTERY DISEASE. FROM THE RESET TRIAL, (B)(4) PATIENTS WITH EVEROLIMUS-ELUTING STENTS WHO UNDERWENT SERIAL OCT EXAMINATION (POST-STENTING AND 12-MONTH FOLLOW-UP) WERE INVESTIGATED. RESULTS: AT POST-STENTING, ACUTE STENT MAL-APPOSITION WAS OBSERVED IN (B)(4) EVEROLIMUS-ELUTING STENTS, AND (B)(4) MAL-APPOSED STENT STRUTS WERE DETECTED. AT 12-MONTH FOLLOW-UP, (B)(4) STENT MAL-APPOSITION WAS RESOLVED, HOWEVER (B)(4) STENT MAL-APPOSITION WAS PERSISTENT. A TOTAL OF (B)(4) PERSISTENT MAL-APPOSED STENT STRUTS WERE DETECTED AT 12-MONTH FOLLOW-UP. THE ROC CURVES SHOWED THAT STENT MAL-APPOSED DISTANCE AT POST-STENTING WAS THE BEST CUT-OFF TO PREDICT PERSISTENT STENT MAL-APPOSITION AT 12-MONTH FOLLOW-UP IN EVEROLIMUS-ELUTING STENTS. CONCLUSIONS: THE STENT WITH MAL-APPOSED DISTANCE AT POST-STENTING HAS A HIGH RISK FOR PERSISTENT STENT MAL-APPOSITION AT 12-MONTH FOLLOW-UP IN EVEROLIMUS-ELUTING STENTS. OCT CAN PREDICT PERSISTENT STENT MAL-APPOSITION AND PROVIDE USEFUL INFORMATION TO OPTIMIZE PERCUTANEOUS CORONARY INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: UNK XIENCE