BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1643828 · Received March 26, 2010

    Report

    Report Number
    2024168-2010-00598
    Event Type
    Injury
    Date Received
    March 26, 2010
    Date of Event
    March 3, 2010
    Report Date
    March 3, 2010
    Manufacturer
    ABBOTT VASCULAR - CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). DISSECTION IN THE IFU IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. DISSECTIONS CAN BE INFLUENCED BY SEVERAL FACTORS INCLUDING, BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. THE IFU STATES: IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE MINI VISION (P.N. 1007821-08, LOT# 8121541) IS BEING REPORTED UNDER A SEPARATE MFR NUMBER. THE OTHER THREE MINI VISIONS ARE BEING REPORTED UNDER THIS SAME MFR NUMBER.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: DISSECTION. ONSET OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT ALREADY HAD 4 STENTS IMPLANTED DURING THIS CASE, WHEN AN INTIMAL DISSECTION WAS NOTED. THE PATIENT HAD A SMALL MID LAD, SO FOUR OVERLAPPING SMALL STENTS WERE USED (TWO 2.0 X 8 MM AND TWO 2.0 X 12 MM) INSTEAD OF ONE LONG ONE. THE 5TH STENT THAT WAS GOING TO TREAT THE DISSECTION WAS INADVERTENTLY INSERTED TOO DISTALLY, SO THE SDS WAS PULLED BACK. UPON REMOVAL THE STENT STRUT CAUGHT ON THE PREVIOUSLY EXPANDED STENTS AND DISLODGED. THE DISLODGED STENT DID NOT MIGRATE. A BALLOON WAS USED TO EMBED THE UNEXPANDED STENT AGAINST THE VESSEL WALL IN AN UNINTENDED SITE. AT THIS TIME, THE CASE WAS ABORTED. THE DISSECTION APPEARED TO HAVE RESOLVED, POSSIBLY WITH THE BALLOON DILATATION. THERE WERE NO ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention (P.N. 1007821-12, LOT# UNK)| STENT: MINI VISIONS (P.N. 1007821-08, LOT# UNK)| (P.N. 1007821-12, LOT# UNK)