BEUDAMED
    FDA Adverse Event Summary report: N

    WINGSPAN STENT SYSTEM

    MDR report key: 1213627 · Received October 23, 2008

    Report

    Report Number
    2939204-2008-00495
    Date Received
    October 23, 2008
    Date of Event
    May 24, 2008
    Report Date
    October 13, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER FOR NO ALLEGATION OF PRODUCT MALFUNCTION OR NON CONFORMANCE CONTRIBUTING TO THE REPORTED EVENT. ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY. BASED ON THE INFORMATION RECEIVED, THE FOLLOWING WAS DETERMINED: THERE WAS NO ISSUE WITH THE IMPLANTATION OF THE STENT DURING THE INDEX PROCEDURE. THERE WAS NO MALFUNCTION OR NONCONFORMANCE OF THE DEVICE USED TO TREAT THE SECOND RESTENOSIS EVENT.

    Description of Event or Problem · 1

    A STENT WAS PLACED TO TREAT A 60% STENOTIC LESION IN THE RIGHT MIDDLE CEREBRAL ARTERY WITHOUT ISSUE. FIVE MONTHS POST PROCEDURE, THE PATIENT PRESENTED WITH EXPRESSIVE APHASIA, DYSARTHRIA AND CONFUSION DUE TO A TRANSIENT ISCHEMIC ATTACK. ANGIOGRAPHY WAS PERFORMED FIVE DAYS LATER REVEALED THERE TO BE 67% IN STENT RESTENOSIS. THIS WAS TREATED WITH ANGIOPLASTY USING A PTA DILATION CATHETER. ANGIOGRAPHY TAKEN AFTER THE ANGIOPLASTY REVEALED A SMALL DISSECTION OF THE VESSEL JUST PROXIMAL TO THE STENT. THE PHYSICIAN DID NOT BELIEVE THAT THIS WAS OF ANY CLINICAL SIGNIFICANCE AND THAT IT DID NOT REQUIRE TREATMENT. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY. TWO MONTHS AFTER THIS EVENT, THE PATIENT PRESENTED WITH EXPRESSIVE APHASIA DUE TO A STROKE. ANGIOGRAPHY REVEALED THAT THERE WAS 73% IN STENT RESTENOSIS. THIS WAS SUCCESSFULLY TREATED WITH ANGIOPLASTY USING A PTA DILATION CATHETER. THE PATIENT HAD AN UNEVENTFUL RECOVERY AND WAS DISCHARGED HOME. THE PATIENT IS CURRENTLY AT HOME AND WAS ASSESSED TO HAVE A MODIFIED RANKIN SCORE OF 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT SYSTEM (NJE) NEUROVASULAR STENT NJE NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. WS030015 11146275

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R (BOSTON SCIENTIFIC)| TWO GATEWAY PTA DILATION CATHETERS