BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1842064 · Received September 23, 2010

    Report

    Report Number
    9616099-2010-00711
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    October 7, 2008
    Report Date
    March 16, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE (B)(4) STUDY, APPROXIMATELY FOUR MONTHS AFTER PRECISE STENT IMPLANTATION, THE PATIENT DEVELOPED A 50% RESTENOSIS. THE TARGET LESION WAS LOCATED IN THE LEFT INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS 60% STENOSED WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS NON-TORTUOUS. PRE-DILATION WAS NOT PERFORMED AND THE ANGIOGUARD XP WAS DEPLOYED BEYOND THE TARGET LESION. THE PRECISE STENT WAS SUCCESSFULLY IMPLANTED. THE LESION WAS POST-DILATED AND THE ANGIOGUARD XP WAS RETRIEVED. NO NEUROLOGICAL SYMPTOMS WERE OBSERVED. AN UNKNOWN STENT WAS SUCCESSFULLY IMPLANTED. ACCORDING TO THE INVESTIGATOR, RESTENOSIS HAD LIKELY OCCURRED DUE TO PLAQUE PROTRUSION AT THE IMPLANTED AREA. THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THUS, IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. RESTENOSIS IS ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION. VESSEL OCCLUSION, RESTENOSIS, OR RECURRENT STRICTURES ARE WELL KNOWN DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE IN-STENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS, AND IT IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. FACTORS THAT MAY HAVE INFLUENCED THIS EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, APPROXIMATELY FOUR MONTHS AFTER PRECISE STENT IMPLANTATION, THE PATIENT EXPERIENCED RESTENOSIS. THE TARGET LESION WAS LOCATED IN THE LEFT INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS 60% STENOSED WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS NON-TORTUOUS. PRE-DILATION WAS NOT PERFORMED AND THE ANGIOGUARD XP WAS DEPLOYED BEYOND THE TARGET LESION. THE PRECISE STENT WAS SUCCESSFULLY IMPLANTED. THE LESION WAS POST-DILATED AND THE ANGIOGUARD XP WAS RETRIEVED. APPROXIMATELY FOUR MONTHS AFTER PRECISE STENT IMPLANTATION, THE LESION WAS RESTENOSED BY 50%. NO NEUROLOGICAL SYMPTOMS WERE OBSERVED. AN UNKNOWN STENT WAS SUCCESSFULLY IMPLANTED. THERE WAS NO POSSIBILITY OF DISSECTION. NO DISTAL DISEASE WAS LEFT UNTREATED. "HEALTHY TISSUE TO HEALTHY TISSUE' WAS COVERED BY THE STENT. RESIDUAL STENOSIS PERCENTAGE WAS 0%. ACCORDING TO THE INVESTIGATOR, RESTENOSIS HAD LIKELY OCCURRED DUE TO PLAQUE PROTUSION AT THE IMPLANTED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE OTW NITINOL STENT SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 13432932

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R