BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2113783 · Received June 3, 2011

    Report

    Report Number
    3003742446-2011-00282
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 11, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED RESTENOSIS AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, POSITIVE FUNCTIONAL STUDY FOR ISCHEMIA, HYPERLIPIDEMIA, HYPERTENSION, HISTORY OF SMOKING, ALLERGY TO AMOXICILLIN, ALLERGY TO AMLODIPINE, HAIRY CELL LEUKEMIA IN 1990 (IN REMISSION), MODERATE AORTIC STENOSIS, SECONDARY ERYTHROCYTOSIS, RIGHT EYE INTRAOCULAR BLEED, GLAUCOMA, POST TRAUMATIC STRESS DISORDER, DEPRESSION, IMPOTENCE, LOW TESTOSTERONE LEVEL, ALLERGIC RHINITIS AND A HISTORY OF CANCER. THE TARGET LESION WAS THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS DESCRIBED AS 70% STENOSED AND DE NOVO. THE LESION WAS PRE-DILATED WITH A 2.5X15MM BALLOON AT UNKNOWN INFLATION PRESSURE BEFORE THE IMPLANT OF A 3.5X18MM CYPHER STENT AT UNKNOWN INFLATION PRESSURE. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI 3 FLOWS WERE RECORDED PRE AND POST-PROCEDURE. PCI WAS PERFORMED NEXT ON A DE NOVO LESION IN THE DISTAL CIRCUMFLEX OF 10MM IN LENGTH IN A 3.0MM VESSEL DIAMETER. THE LESION WAS CLASSIFIED AS B1. PRE-DILATATION WAS PERFORMED WITH A 2.5X15MM BALLOON AT 16 ATM BEFORE A 3.0X18MM CYPHER STENT AT UNKNOWN INFLATION PRESSURE. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI 3 FLOWS WERE RECORDED PRE AND POST-PROCEDURE. APPROXIMATELY SIX MONTHS POST INDEX PROCEDURE, THE PATIENT RETURNED FOR CONTINUING ANGINA AND RECEIVED XIENCE STENT IN THE 1ST DIAGONAL. "CATH SHOWED WIDELY PATENT CYPHER STENTS, WITH NEW DISEASE IN A LARGE BRANCHING DIAGONAL." THE SUBJECT WAS DISCHARGED HOME AFTER AN OVERNIGHT STAY AND IS ANGINA FREE SINCE. IT IS UNKNOWN IF THE NEW LESION WAS WITHIN 5 MM OF THE PREVIOUSLY PLACED STENT AND THEREFORE, IS BEING CAPTURED AS RESTENOSIS. THE STERILE LOT NUMBER FOR THE DEVICE IS UNKNOWN; THEREFORE, A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AND THE PROGRESSION OF CORONARY ARTERY DISEASE. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THE PATIENT'S MEDICAL HISTORY MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NOTHING IN THE REPORTED INFORMATION TO INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE; THEREFORE, NO ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES ((B)(6) 2010): 2.5X15MM BALLOON. CONCOMITANT DEVICES ((B)(6) 2011): XIENCE STENT. CONCOMITANT MEDICATIONS ((B)(6) 2010): PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, BETA-BLOCKERS, CLONAZEPAM, FLUNISOLIDE, METOPROLOL AND VARDENAFIL. INTRA-PROCEDURE MEDICATION INCLUDED HEPARIN. POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, BETA-BLOCKERS, CLONAZEPAM, FLUNISOLIDE, METOPROLOL AND VARDENAFIL. THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY APPROXIMATELY SIX MONTHS POST INDEX PROCEDURE THE PATIENT RETURNED FOR CONTINUING ANGINA AND RECEIVED XIENCE STENT IN THE 1ST DIAGONAL. "CATH SHOWED WIDELY PATENT CYPHER STENTS, WITH NEW DISEASE IN A LARGE BRANCHING DIAGONAL." THE SUBJECT WAS DISCHARGED HOME AFTER AN OVERNIGHT STAY AND IS ANGINA FREE SINCE. DURING THE INDEX PROCEDURE, PCI WAS PERFORMED ON A 70% DE NOVO LESION IN THE PROXIMAL LAD OF 15MM IN LENGTH IN A 3.3MM VESSEL DIAMETER. THE LESION WAS CLASSIFIED AS B1. PRE-DILATATION WAS PERFORMED WITH A 2.5X15MM BALLOON AT UNKNOWN INFLATION PRESSURE BEFORE A 3.5X18MM CYPHER STENT AT UNKNOWN INFLATION PRESSURE. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI 3 FLOWS WERE RECORDED PRE AND POST-PROCEDURE. PCI WAS PERFORMED NEXT ON A DE NOVO LESION IN THE DISTAL CIRCUMFLEX OF 10MM IN LENGTH IN A 3.0MM VESSEL DIAMETER. THE LESION WAS CLASSIFIED AS B1. PRE-DILATATION WAS PERFORMED WITH A 2.5X15MM BALLOON AT 16 ATM BEFORE A 3.0X18MM CYPHER STENT AT UNKNOWN INFLATION PRESSURE. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI 3 FLOWS WERE RECORDED PRE AND POST-PROCEDURE.

    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) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R