BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK 8

    MDR report key: 3242825 · Received July 23, 2013

    Report

    Report Number
    2024168-2013-04609
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FAILURE TO FOLLOW STEPS/INSTRUCTIONS. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MISSING/DISLODGED STENT WAS LIKELY DUE TO HANDLING DURING PROTECTIVE SHEATH REMOVAL. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE SIMILAR INCIDENTS COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE MULTI-LINK 8 INSTRUCTIONS FOR USE INSTRUCTS THE USER TO INSPECT AND VERIFY STENT LOCATION. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN AN UNSPECIFIED VESSEL, AFTER DEPLOYMENT OF A RX MULTI-LINK 8 STENT SYSTEM, THE STENT COULD NOT BE LOCATED IN THE VESSEL OR ANATOMY VIA X-RAY. THE CATH LAB WAS CHECKED DURING AND AFTER THE PROCEDURE AND THE STENT WAS NOT FOUND. THE LOCATION OF THE STENT COULD NOT BE DETERMINED. ANOTHER STENT WAS DEPLOYED SUCCESSFULLY AT THE TARGET LESION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE INNER SEAL ON THE STERILE PACKAGING WAS CONFIRMED TO BE SEALED AND SECURE PRIOR TO THE PROCEDURE. REPORTEDLY, THE STENT WAS NOT CLOSELY INSPECTED PRIOR TO USE AND DURING DEVICE PREPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343681 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 3020741

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention