BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUTLI-LINK RX TETRA CORONARY STENT SYSTEM

    MDR report key: 831282 · Received March 22, 2007

    Report

    Report Number
    2024168-2007-00103
    Event Type
    Injury
    Date Received
    March 22, 2007
    Report Date
    February 20, 2007
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - QUALITY ENGINEERING REVIEWED THE INCIDENT INFO; HOWEVER, THE DEVICE WAS NOT RETURNED TO ABBOTT FOR ANALYSIS. STENOSIS AND ISCHEMIA, AS LISTED IN THE INSTRUCTIONS FOR USE (IFU) ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE CORONARY STENTING PROCEDURE.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQURING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED IN AN ARTICLE TITLED "CATHETERIZATION AND CARDIOVASCULAR INTERVENTION 69:223-226 (2007)" PRINTED IN WILEY INTERSCIENCE, THAT THE PT HAD A HEAVILY THROMBOSED MIDLEFT ANTERIOR DESCENDING STENOSIS 5 1/2 YEARS AGO THAT WAS TREATED WITH A 3.5X18 MM TETRA STENT. THE TETRA STENT WAS DIRECTLY DEPLOYED IN THE PT USING AN EBU-4 (MEDTRONIC) GUIDE CATHETER. LATER, THE PT COMPLAINED OF DIZZINESS AND DYSPNEA, AND A NUCLEAR STRESS TEST SUGGESTED ANTERIOR ISCHEMIA. THE PT WAS SCHEDULED FOR CARDIAC CATHETERIZATION WITH POSSIBLE CORONARY REVASCULARIZATION AND RECEIVED ACETYLCYSTEINE AND SODIUM BICARBONATE PRETREATMENT FOR RENAL PROTECTION. A REPEAT TRANSRADIAL CATHETERIZATION REVEALED A FOCAL 90% IN-STENT RESTENOSIS IN THE MIDLEFT ANTERIOR DESCENDING ARTERY. THE STENOSIS WAS EASILY DIRECTLY STENTED WITH A TAXUS DRUG-ELUTING STENT WITHOUT RESIDUAL STENOSIS AND THE PT WAS DISCHARGED THE FOLLOWING DAY WITH A STABLE CREATININE LEVEL. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MUTLI-LINK RX TETRA CORONARY STENT SYSTEM 74MAF MAF GUIDANT VASCULAR INTERVENTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention GUIDE CATH: EBU-4 (MEDTRONIC)