BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXSTENT MONORAIL

    MDR report key: 1153078 · Received September 8, 2008

    Report

    Report Number
    2134265-2008-02563
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIM
    PMA / PMN Number
    P050025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN REC'D FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL REGISTRY . IT WAS REPORTED THAT 247 DAYS AFTER A CAROTID ARTERY STENTING TREATMENT PROCEDURE, THE PT EXPERIENCED IN-STENT RESTENOSIS AND REQUIRED A TARGET VESSEL REINTERVENTION. THE TARGET LESION WAS LOCATED IN THE OSTIUM RIGHT INTERNAL CAROTID ARTERY, WITH A 90% STENOSIS AND WAS 10 MM LONG WITH A 6 MM REFERENCE VESSEL DIAMETER. THE PHYSICIAN TREATED THE LESION WITH A PLACEMENT FOR A FILTER WIRE EZ AND A 4-9 X 30 MM NEXSTENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 10%. THE PT WAS DISCHARGED THE NEXT DAY. AT 223 AFTER THE INDEX PROCEDURE, THE PT WAS SEEN FOR A ROUTINE POST-CAROTID F/U APPOINTMENT. A CAROTID DUPLEX REVEALED INCREASED VELOCITIES, SEVERE NEAR 80% STENOSIS ON A PREVIOUS PLACED RIGHT CAROTID STENT, AND EVIDENCE OF PROXIMAL LEFT SUBCLAVIAN STENOSIS. THE PT WAS RECOMMENDED FOR A REPEAT CAROTID ANGIOGRAM AND IF NECESSARY, A POSSIBLE STENTING OR ANGIOPLASTY PROCEDURE. AT 247 DAYS POST INDEX, THE PT PRESENTED FOR AN ARCH AND CAROTID ANGIOGRAM. A CAROTID DUPLEX REVEALED INCREASED VELOCITIES IN THE RIGHT INTERNAL CAROTID SUGGESTING POSSIBLE IN-STENT RESTENOSIS. THE FOLLOWING WERE PERFORMED. AN ARCH AORTOGRAM REVEALED AN 80% STENOSIS IN THE RIGHT AND LEFT SUBCLAVIAN ARTERIES. VERTEBRAL ARTERIES ARE PATENT. A RIGHT CAROTID AND CEREBRAL ANGIOGRAM REVEALED A 70-80% IN-STENT RESTENOSIS WITHIN THE PROXIMAL CAROTID AT THE ORIGIN OF THE ICA. A LEFT CAROTID CERVICAL CEREBELLAR ANGIOGRAM REVEALED SOME CALCIFIC PLAQUE BUT WIDELY PATENT LEFT INTERNAL CAROTID. THE LEFT SUBCLAVIAN ARTERY STENOSIS WAS TREATED WITH BALLOON ANGIOPLASTY RESULTING IN AN APPROX 50% RESIDUAL STENOSIS. EXPRESS LD STENT OF 8 MM X 017 MM WAS PLACED WITH NO RESIDUAL STENOSIS.. FOLLOWING THE PROCEDURE, THE PT DEVELOPED A FEVER. THE PRINCIPAL INVESTIGATOR WAS NOTIFIED AND THE PT WAS ADMITTED OVER NIGHT FOR OBSERVATION. ADMISSION NOTES INDICATE THE FEVER WAS A RESULT OF THE PT'S PROCEDURE EARLIER IN THE DAY. THE PT WAS DISCHARGED THE NEXT DAY. AT 267 DAYS AFTER THE INDEX PROCEDURE, THE PT UNDERWENT A SUCCESSFUL RIGHT CAROTID ENDARTERECTOMY WITH HEMASHIELD PATCH AND EXCISION AND REMOVAL OF THE RIGHT CAROTID STENT. SOURCE DOCUMENTS NOTE THAT STENT INCORPORATED INTO THE INTIMA AND THERE WAS SIGNIFICANT GROWTH OF PLAQUE AND INTIMAL HYPERPLASIA THROUGH THE STENT AT THE MAIN PART AND ALSO OUTSIDE THE STENT THAT WAS PUSHING THE STENT MEDIALLY. FOLLOWING THE PROCEDURE, THERE WAS 0% STENOSIS AND NO THROMBUS PRESENT. THE PT WAS DISCHARGED THE NEXT DAY. IN THE OPINION OF THE PHYSICIAN THE RELATIONSHIP OF THE RESTENOSIS TO THE NEXSTENT IS PROBABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXSTENT MONORAIL NIM STENT, CAROTID NIM BOSTON SCIENTIFIC NA C71301

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R