BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 996633 · Received February 7, 2008

    Report

    Report Number
    2024168-2008-00086
    Event Type
    Injury
    Date Received
    February 7, 2008
    Date of Event
    January 5, 2008
    Report Date
    January 8, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION/PERMANENT DAMAGE. REPORTING RATIONALE: STENT DISLODGED; COMPRESSED AGAINST VESSEL WALL AT UNINTENDED SITE. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE STENT HAD DISLODGED DURING A PROCEDURE PERFORMED IN 2007; HOWEVER, IT WAS NOT NOTED AND ONLY DISCOVERED AFTER ANOTHER PROCEDURE IN 2008. DURING THE FIRST PROCEDURE, AN ATTEMPT WAS MADE TO ADVANCE TWO MINI VISION STENTS; FIRST A MINI VISION 2.5 X 8 MM (LOT# 7071331) FOLLOWED BY A MINI VISION 2.0 X 8MM. IT WAS ASSUMED THAT THE UNDEPLOYED MINI VISON 2.0 X 8MM HAD FALLEN OFF THE BALLOON AND WAS LEFT IN THE PROXIMAL LAD. DURING THE SECOND PROCEDURE THE STENT WAS DISLODGED FROM THE CLOT IN THE PROXIMAL LAD BY THE PHYSICIAN WITH ANOTHER COMPANY'S STENT. THE UNDEPLOYED STENT LANDED DOWN STREAM IN THE MID/DISTAL LAD AND WENT UNRECOGNIZED. THE PT CONTINUED TO HAVE PAIN AND AFTER RE-EXAMINING THE PICTURES THE STENT WAS IDENTIFIED. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE STENT WITH NO SUCCESS. THE PHYSICIAN CONTINUED WITH COMPRESSING THE STENT AGAINST THE VESSEL WALL WITH THE DEPLOYMENT OF ANOTHER COMPANY'S STENT. NO ADD'L EVENT OR PATIENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 6081631

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R| S SNARE| OTHER: IABP| STENT: TAXUS (2.5 X 16MM)| CYPHER (2.5 X 13MM| MINI VISION (2.5 X 8MM