BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIVISION

    MDR report key: 1812381 · Received August 24, 2010

    Report

    Report Number
    MW5017170
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    May 2, 2010
    Report Date
    August 24, 2010
    Manufacturer
    ABBOTT VASCULAR DEVICES
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT TRANSFERRED FROM OUTLYING FACILITY WHERE STEMI WAS IDENTIFIED, FOR EMERGENT CATH/PCI. SEVERAL EPISODES OF VTACH AT OUTLYING FACILITY, SEDATED, CARDIOVERTED, AND INTUBATED. FILMS REVEALED 100% OCCLUSION OF OM2. DILATED WITH 2.0X15 VOYAGER, AND A 2.5X18 MULTILINK MINIVISION DEPLOYED. FINAL FILMS REVEALED GOOD ANGIOGRAPHIC RESULT. MEDICATIONS INCLUDING ASA, PLAVIX, AND HEPARIN. TO CCU AT 0135. EPISODE OF VTACH AND CARDIOGENIC SHOCK. RETURNED TO CCL AT 0926. RELOOK ANGIOGRAPHY REVEALS 95% STENOSIS OF OM2 AT PREVIOUSLY PLACED STENT WITH THROMBUS. DILATED WITH 2.5X15 VOYAGER SERIAL INFLATIONS. CONCERN FOR DISTAL EDGE DISSECTION, AND DECISION MADE TO PLACE A 2.0X18 MULTILINK MINIVISION. POST DILATED WITH THE VOYAGER. FINAL FILMS REVEAL GOOD ANGIOGRAPHIC RESULT. DECISION MADE TO PLACE IABP. PATIENT RETURNED TO CCU. DISCHARGED TO NURSING HOME (B)(6)2010 WITH MEDS INCLUDING ASA AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIVISION MULTILINK MINIVISION NIQ ABBOTT VASCULAR DEVICES * 0031041

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Disability