BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2091730 · Received May 17, 2011

    Report

    Report Number
    3003742446-2011-00250
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    January 27, 2010
    Report Date
    April 19, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00251, 3003742446-2011-00252, AND 3003742446-2011-00253. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM THE (B)(4) INDICATED THAT A PATIENT EXPERIENCED A DISSECTION AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE STENTS WAS REPORT OF INSUFFICIENT FLOW AFTER THE STENTS WERE IMPLANTED REQUIRING POST-DILATION. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR (B)(6), PREVIOUS PCI, TARGET VESSEL PREVIOUS REVASCULARIZED ((B)(6) 2009), PERIPHERAL ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, ATRIAL FIBRILLATION, MYOCARDIAL INFARCTION ((B)(6) 2009), PVD/CLAUDICATION, COPD, DIABETES, AND SMOKING. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE ANGINA PECTORIS. THE TARGET LESIONS WERE THE 1ST OBTUSE MARGINAL (OM1) AND THE MID RIGHT CORONARY ARTERY (RCA). THE 1ST TARGET LESION WAS THE 1ST OM. VESSEL DIAMETER WAS 2.5MM AND THE LESION LENGTH WAS 23MM. THE LESION WAS AN IN-STENT RESTENOSIS OF A BARE METAL STENT. PRE-PROCEDURE STENOSIS WAS 90%. THE LESION WAS DIRECT STENTED WITH A 2.50MM X 28MM CYPHER STENT WAS IMPLANTED AT 14ATM, FOLLOWED BY THE IMPLANT OF A 2.50MM X 13MM CYPHER STENT AT 14 ATM PROXIMAL AND OVERLAPPING THE FIRST STENT. THE STENTS WERE POST-DILATED DUE TO INSUFFICIENT FLOW WITH A 2.5 X 20MM BALLOON AT 18ATM. THE 2ND TARGET LESION WAS THE MID RCA. VESSEL DIAMETER WAS 3MM AND THE LESION LENGTH WAS 23MM. THE LESION WAS AN IN-STENT RESTENOSIS OF A BARE METAL STENT. PRE-PROCEDURE STENOSIS WAS 95%. THE LESION WAS DIRECT STENTED WITH A 3.0MM X 28MM CYPHER STENT FOLLOWED BY A 3.0MM X 8MM CYPHER STENT AT 14 ATMS PROXIMAL AND OVERLAPPING THE FIRST TO FULLY COVER THE LESION. A DISSECTION OCCURRED AND THE (B)(4) WAS POST-DILATED WITH A 2.5 X 20MM BALLOON AT 18ATM TO TREAT THE DISSECTION. THE REPORTED RESIDUAL STENOSIS WAS 0% AND THE PATIENT WAS DISCHARGED THE SAME DAY. 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. DISSECTION AND INSUFFICIENT FLOW FOLLOWING STENT IMPLANTATION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. THESE EVENTS CAN BE RELATED TO LESION CHARACTERISTICS AND INHERENT RISK OF THE PROCEDURE. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    THE REPORT WAS RECEIVED FROM THE (B)(4) STUDY. THE PATIENT WAS A (B)(6) MALE WITH A HISTORY OF OBESITY, PREVIOUS PCI, TARGET VESSEL PREVIOUS REVASCULARIZED ((B)(6) 2009), PERIPHERAL ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, ATRIAL FIBRILLATION, MYOCARDIAL INFARCTION ((B)(6) 2009), PVD/CLAUDICATION, COPD, DIABETES, AND SMOKING. INDICATION FOR THE INDEX PROCEDURE WAS STABLE ANGINA PECTORIS. THE TARGET LESIONS WERE THE 1ST OM AND THE MID RCA. THE 1ST TARGET LESION WAS THE 1ST OM. VESSEL DIAMETER WAS 2.5MM AND THE LESION LENGTH WAS 23MM. THE LESION WAS AN IN-STENT RESTENOSIS OF A BARE METAL STENT. PRE-PROCEDURE STENOSIS WAS 90%. A CXS28250 WAS DEPLOYED AT 14ATM. THE 2ND STENT WAS A CXS13250, DEPLOYED AT 14ATM, OVERLAPPING THE FIRST STENT. THE STENTS WERE POST-DILATED DUE TO INSUFFICIENT FLOW. POST-DILATION WAS CONDUCTED WITH A 2.5 X 20MM BALLOON AT 18ATM. THE 2ND TARGET LESION WAS THE MID RCA. VESSEL DIAMETER WAS 3MM AND THE LESION LENGTH WAS 23MM. THE LESION WAS AN IN-STENT RESTENOSIS OF A BARE METAL STENT. PRE-PROCEDURE STENOSIS WAS 95%. A CXS28300 WAS DEPLOYED AT 14ATM. A CXS08300 WAS DEPLOYED AT 14ATM, OVERLAPPING WITH THE FIRST. A DISSECTION OCCURRED AND THE CXS08300 WAS POST-DILATED WITH A 2.5 X 20MM BALLOON AT 18ATM TO TREAT THE DISSECTION. POST-PROCEDURE STENOSIS WAS 0%. PATIENT WAS DISCHARGED THE SAME DAY.

    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 15077172

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention ASPIRIN, CLOPIDOGREL, BIVALRUDIN