BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS RX MULTI-LINK HP CORONARY STENT SYSTEM

    MDR report key: 249858 · Received November 11, 1999

    Report

    Report Number
    2024168-1999-00346
    Event Type
    Injury
    Date Received
    November 11, 1999
    Date of Event
    October 15, 1999
    Report Date
    October 15, 1999
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY/STENT PROCEDURE, ANOTHER COMPANY'S STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO ADVANCE THE LESION; HOWEVER, THIS WAS UNSUCCESSFUL. THIS RESULTED IN STENT SEPARATION AND SUBSEQUENT RETRIEVAL WITH A SNARE. THE MULTILINK SDA WAS INTRODUCED; HOWEVER, THE STENT ALSO SEPARATED FROM THE SDS PROXIMAL TO THE LESION. THE STENT WAS EASILY REMOVED. SUBSEQUENT INSPECTION OF THE USED STENT REVEALED THAT A PIECE OF THE ELASTIC MEMBRANE WAS MISSING. THE PIECE WAS RETRIEVED FROM THE CORONARY UTILIZING A GOOSE NECK SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS RX MULTI-LINK HP CORONARY STENT SYSTEM Implant CORONARY STENT SYSTEM MAF GUIDANT VASCULAR INTERVENTION NA 8102651

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| L| R MULTILINK HP 3.0X15 GFX II 3.0X18 STENT.| SCIMED RHV, 7FR TERUMO SHEATH,| 7FR CYBER FL4 GUIDING CATHETER,| FLOPPY II GUIDE WIRE,| GALE 2.0X20 FLEXSTREAM 3.0X20 DILATATION CATHETER,| SCIMED INFLATION DEVICE,