BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1944861 · Received January 3, 2011

    Report

    Report Number
    3003742446-2011-00009
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 21, 2010
    Report Date
    December 8, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A (B)(6) PATIENT FROM THE (B)(4) STUDY EXPERIENCED A CORONARY ARTERY DISSECTION POST IMPLANTATION OF A CYPHER STENT. PAST MEDICAL HISTORY INCLUDES PREVIOUS PCI, POSITIVE FUNCTIONAL TEST FOR ISCHEMIA, HYPERLIPIDEMIA, AND HYPERTENSION. PCI WAS CONDUCTED TO TREAT AN 80% STENOSED LESION IN THE MID RCA. THE LESION WAS DESCRIBED AS TYPE B1, 10 MM IN LENGTH IN A 4.0 MM VESSEL DIAMETER AND MODERATELY TORTUOUS. THE LESION WAS NOT PRE-DILATED BEFORE THE IMPLANTATION OF A 3.5X18 MM CYPHER AT 16 ATM. CYPHER IS INDICATED FOR USE IN LESIONS JUDGED TO BE AMENABLE TO COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. DURING DEPLOYMENT, A DISTAL EDGE DISSECTION WAS NOTED. A SECOND CYPHER (3.5X8 MM) WAS DEPLOYED OVERLAPPING AND DISTAL TO THE INITIAL STENT TO TREAT THE EDGE DISSECTION SUCCESSFULLY AND THE EVENT RESOLVED WITHOUT SEQUELAE. THE RESIDUAL STENOSIS MEASURED 0% AND TIMI III FLOW WAS REPORTED. TROPONIN LEVELS MEASURED 12 HRS POST-PROCEDURE WERE THE SAME AS COLLECTED PRE-PROCEDURE (0.25 NG/ML). THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. DISSECTIONS ARE KNOWN POTENTIAL ADVERSE EVENTS DURING PCI. IN THE PRECAUTIONS SECTION OF THE IFU IT INDICATES THAT IMPLANTING A STENT MAY LEAD TO A DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENTED PORTION AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION, I.E. PLACEMENT OF ADDITIONAL STENTS. THIS IS AN INHERENT RISK OF THE PROCEDURE. BASED ON THE INFORMATION AVAILABLE, THERE ARE POSSIBLE VESSEL CHARACTERISTICS (TORTUOSITY) AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT UNDERWENT INDEX STENTING OF THE MID RCA ON (B)(6), 2010. DURING DEPLOYMENT OF THE CYPHER STENT IN THE MID RCA, AN EDGE DISSECTION WAS NOTED. A SECOND CYPHER WAS DEPLOYED OVERLAPPING AND DISTAL TO THE INITIAL STENT TO TREAT THE EDGE DISSECTION SUCCESSFULLY. THERE WERE NO ADVERSE SEQUELAE REPORTED FROM THE DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) 15195923

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention