BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ STENT UNKNOWN

    MDR report key: 2040422 · Received April 5, 2011

    Report

    Report Number
    9610978-2011-00067
    Event Type
    Injury
    Date Received
    April 5, 2011
    Report Date
    March 9, 2011
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF JOURNAL ARTICLE: RESTENOSIS AFTER ENDOVASCULAR PTA/STENTING FOR SUPRA-AORTIC BRANCHES IN TAKAYASU'S AORTITIS, IT WAS NOTED THAT A (B)(6) FEMALE PATIENT TAKING CORTICOSTEROIDS AND IMMUNOSUPPRESSANTS FOR TAKAYASU'S AORTITIS COMPLAINED OF PROGRESSING RIGHT-HAND WEAKNESS. IADSA SHOWED SEVERE STENOSIS AT THE RIGHT SUBCLAVIAN ARTERY, AND THE PATIENT UNDERWENT PTA/STENTING WITH A PALMAZ STENT. THE STENT SHOWED RESTENOSIS 3 MONTHS LATER. THE PATIENT HAS BEEN TREATED CONSERVATIVELY FOR THE RESTENOSIS SINCE THERE WERE NO SYMPTOMS AFTER THE INITIAL TREATMENT. NO ADDITIONAL PATIENT, LESION/VESSEL OR PROCEDURAL INFORMATION IS AVAILABLE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. IN-STENT RESTENOSIS (ISR) IS ASSOCIATED WITH THE PROGRESSION OF ATHEROSCLEROTIC DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND DOES NOT REPRESENT A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS, IT IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. VESSEL OCCLUSION, RESTENOSIS, INTIMAL HYPERPLASIA OR RECURRENT STRICTURES ARE WELL KNOWN DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. FACTORS THAT MAY HAVE INFLUENCED THIS EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION.

    Description of Event or Problem · 1

    JOURNAL ARTICLE: HORIE ET AL: IN RESTENOSIS AFTER ENDOVASCULAR PTA/STENTING FOR SUPRA-AORTIC BRANCHES IN TAKAYASU AORTITIS: REPORT OF THREE CASES AND REVIEW OF THE LITERATURE, DOI 10.1007/S00701-010-0932-Y; REPORT THAT A (B)(6) FEMALE PATIENT TAKING CORTICOSTEROIDS AND IMMUNOSUPPRESSION FOR TAKAYASU AORTITIS COMPLAINED OF PROGRESSING RIGHT-HAND WEAKNESS. IADSA SHOWED SEVERE STENOSIS AT THE RIGHT SUBCLAVIAN ARTERY, AND THE PATIENT UNDERWENT PTA/STENTING WITH A PALMATZ STENT R (7X17.8 MM, CORDIS). THE STENT SHOWED RESTENOSIS 3 MONTHS LATER, AND THE PATIENT'S INFLAMMATORY STATUS WAS NOT STABLE. THE PATIENT HAS BEEN TREATED CONSERVATIVELY FOR THE RESTENOSIS SINCE THERE WERE NO SYMPTOMS AFTER THE INITIAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ STENT UNKNOWN ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR