BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 917323 · Received September 20, 2007

    Report

    Report Number
    2024168-2007-00393
    Event Type
    Injury
    Date Received
    September 20, 2007
    Date of Event
    December 27, 2006
    Report Date
    August 24, 2007
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND RX MINI VISION PART# 1007829-12, LOT# 6092231, IS INDICATED IN THE EVENT DESCRIPTION, AND IS BEING REPORTED UNDER THE SAME MANUFACTURER NUMBER. RESULTS AND CONCLUSION SUMMATION: PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE DEVICES BECAUSE THEY WERE NOT RETURNED FOR EVALUATION. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION. RESTENOSIS, AS LISTED IN THE INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY-MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT TWO MINI-VISION STENTS WERE PLACED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. ANOTHER COMPANY'S 2.5 X 16 STENT WAS PLACED IN THE CIRCUMFLEX, AND A 3.5 X 19 (ALSO FROM THE OTHER COMPANY) WAS PLACED IN THE RAO. IN 2006, THE PATIENT WAS REINTERVENED, AND AN ANGIOGRAPHY SHOWED THAT THE STENT IN THE LAD WAS RESTENOSED 60% INNER STENT. AS A RESULT, A VISION 3.0 X 18 STENT WAS PLACED IN THE LAD INNER STENT. THE PATIENT WAS REINTERVENED AGAIN IN EARLY 2007, AND AN ANGIOGRAPHY REVEALED THAT THE LAD HAD A DIFFUSE STENOSIS INNER STENT AND THE OTHER COMPANY'S STENT IN THE CIRCUMFLEX HAD A 70% INNER STENT RESTENOSIS, AND THE OTHER STENT IN THE RAO HAD 50% STENT RESTENOSIS. THE PATIENT WAS SENT TO SURGERY. NO ADDITIONAL EVENT OR PATIENT INFORMATION 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 6090531

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention BIO-DIVISION 3.5 X 19| BIO-DIVISION 2.5 X 16| (PART# 1007829-12/LOT# 6092231)| STENT: MULTI-LINK MINI VISION RX