BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK CORONARY STENT SYSTEM

    MDR report key: 2972439 · Received February 21, 2013

    Report

    Report Number
    2024168-2013-01012
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 25, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. IMPLANT DATE ESTIMATED. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND RESTENOSIS, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL XIENCE STENT REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THE ADDITIONAL ADVERSE PATIENT EFFECT OF DEATH REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH ARTICLE REVIEW THAT IN A (B)(4), LESION LENGTH DEFINED IN TERTILES HAS NO IMPACT ON THE SHORT-TERM IN-STENT RESTENOSIS (ISR) OR LONG-TERM MAJOR ADVERSE CARDIAC EVENT (MACE) OUTCOMES OF PATIENTS IMPLANTED WITH DRUG ELUTING STENTS. IN CONTRAST, LONGER LESION CORRELATES WITH HIGHER ISR AND MACE RATES IN THE BARE METAL STENT GROUP. IN THIS (B)(4), A TOTAL OF (B)(6) CONSECUTIVE PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS WHO HAD UNDERGONE SUCCESSFUL EMERGENCY OR ELECTIVE PERCUTANEOUS CORONARY INTERVENTION BETWEEN (B)(6) 1996 AND (B)(6) 2010 WERE REGISTERED. OF THE (B)(4) PATIENTS, THE FOLLOWING OUTCOMES WERE CAPTURED: DEATH, REVASCULARIZATION, MYOCARDIAL INFARCTION, CORONARY ARTERY BYPASS GRAFTING. ABBOTT VASCULAR BARE METAL STENTS USED DURING THIS STUDY ARE: MULTI-LINKS (DUET, TRISTAR, PENTA, PIXEL AND VISION). A DIRECT CORRELATION TO ANY ONE OF THESE STENTS TO THE PATIENT OUTCOMES IS UNABLE TO BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76446 MULTI-LINK CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S