BEUDAMED
    FDA Adverse Event Summary report: N

    WINGSPAN STENT

    MDR report key: 1912811 · Received December 2, 2010

    Report

    Report Number
    2939204-2010-01128
    Date Received
    December 2, 2010
    Report Date
    November 29, 2010
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. THROMBUS IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    LITERATURE: COSTALAT ET AL, NEUROSURGERY 2010: 67(6); 1505-15 - ATTACHMENT: [2939204-2010-01128_MALDONADO_NEUROSURGERY_DEC2010.PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN NEUROSURGERY THAT THE PATIENT SUFFERED AN EMBOLIC OCCLUSION OF THE LEFT POSTERIOR CEREBRAL ARTERY (PCA) P1 SEGMENT DURING THE TREATMENT OF A BASILAR ARTERY STENOSIS. THE PATIENT WAS IMMEDIATELY TREATED WITH AN INTRA-ARTERIAL INFUSION OF A ABCIXIMAB WITHOUT ANY SIGNIFICANT ANGIOGRAPHIC EFFECT. AT SIX-MONTH FOLLOW-UP, AN MRI CONFIRMED THE PERSISTENCE OF VESSEL PATENCY IN THE BASILAR ARTERY AND THERE WERE A CALCIC EMBOLUS IN THE LEFT PCA AND RESIDUAL OPACIFICATION OF THE DISTAL PART OF THE VESSEL. CLINICAL SCORES REMAINED UNCHANGED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN NEUROSURGERY THAT THE PATIENT SUFFERED AN EMBOLIC OCCLUSION OF THE LEFT POSTERIOR CEREBRAL ARTERY (PCA) P1 SEGMENT DURING THE TREATMENT OF A BASILAR ARTERY STENOSIS. THE PATIENT WAS IMMEDIATELY TREATED WITH AN INTRA-ARTERIAL INFUSION OF A ABCIXIMAB WITHOUT ANY SIGNIFICANT ANGIOGRAPHIC EFFECT. AT SIX-MONTH FOLLOW-UP, AN MRI CONFIRMED THE PERSISTENCE OF VESSEL PATENCY IN THE BASILAR ARTERY AND THERE WERE A CALCIC EMBOLUS IN THE LEFT PCA AND RESIDUAL OPACIFICATION OF THE DISTAL PART OF THE VESSEL. CLINICAL SCORES REMAINED UNCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT STENT, INTRACRANIAL NEUROVASCULAR NJE UNK484

    Patients

    Seq Age Sex Outcome Treatment
    1 GATEWAY PTA BALLOON CATHETER (BOSTON SCIENTIFIC)