BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDERFX¿ EMBOLIC PROTECTION DEVICE

    MDR report key: 2880081 · Received December 19, 2012

    Report

    Report Number
    2183870-2012-00241
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    September 10, 2012
    Report Date
    December 6, 2012
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN (B)(6) AND IS PART OF THE (B)(6) STUDY. THE PROCEDURE DATE WAS (B)(6), 2012. A DISTAL EMBOLISM (PLAQUE, THROMBUS, OR DEBRIS) WAS REPORTED. PTA WAS PERFORMED WITHIN THE STUDY PROCEDURE OF THE PERONEAL ARTERY. DESPITE THE USE OF THE SPIDERFX FILTER, POST PROCEDURAL OCCLUSION OF THE PERONEAL ARTERY OCCURRED DUE TO SMALL EMBOLUS. REVASCULARIZATION BY BALLOON ANGIOPLASTY WAS PERFORMED. PLEASE REFERENCE MDR 2183870-2012-00240 FOR THE TURBOHAWK USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERFX¿ EMBOLIC PROTECTION DEVICE TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE EV3 INC. SPD2-070-190 9577410

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention COTAVANCE BALLOON| AVANT CORDIS 7F SHEATH| TURBOHAWK