BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2201621 · Received August 11, 2011

    Report

    Report Number
    3003742446-2011-00383
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    November 11, 2010
    Report Date
    July 15, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED RESTENOSIS TWICE AND ANGINA AFTER HAVING MULTIPLE CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, PREVIOUS PCI ((B)(6) 2005), HYPERLIPIDEMIA, HYPERTENSION, DIABETES, AND A FAMILY HISTORY CORONARY ARTERY DISEASE. THE INDICATION FOR AN INTERVENTION WAS STABLE ANGINA PECTORIS. THE TARGET LESION WAS THE MID RIGHT CORONARY ARTERY (RCA), DESCRIBED AS 3MM IN DIAMETER, 50MM IN LENGTH, MODERATELY TORTUOUS AND 90% STENOSED. THE LESION WAS A RESTENOSIS OF AN UNKNOWN PREVIOUSLY IMPLANTED DRUG ELUTING STENT. THE LESION WAS PRE-DILATED WITH 2 BALLOONS (2.5 X 15MM BALLOON) AT 15ATM. THE 1ST STENT DEPLOYED WAS A (B)(4) AT 15ATM. THE STENT WAS POST-DILATED WITH A 3 X 15MM BALLOON AT 15ATM. A (B)(4) DEPLOYED AT 15ATM, OVERLAPPING AND PROXIMAL TO THE 1ST STENT. THE 3RD STENT, A (B)(4) WAS DEPLOYED AT 14ATM, OVERLAPPING AND PROXIMAL TO THE PREVIOUS STENT. THE STENT WAS POST-DILATED WITH A 3 X 15MM BALLOON AT 15ATM. POST-PROCEDURE STENOSIS WAS 0%. THREE DAYS LATER THE PATIENT HAD A PLANNED STAGED PROCEDURE DUE TO EXCESSIVE DYE. THE TARGET LESIONS WERE THE 2ND OM AND THE PROXIMAL CFX. THE 2ST OM WAS 3.5MM IN DIAMETER AND THE LESION WAS 24MMIN LENGTH. THE VESSEL WAS HEAVILY CALCIFIED AND A CLASSIFICATION B2. THE LESION WAS DE NOVO AND 80% STENOSED. THE LESION WAS PRE-DILATED WITH A 3.5 X 15MM BALLOON AT 18ATM. A (B)(4) WAS DEPLOYED AT 12ATM. THE PROX CFX WAS 3.5MM IN DIAMETER AND THE LESION WAS 26MM LONG. THE VESSEL WAS MODERATELY CALCIFIED AND A CLASSIFICATION B2. THE LESION WAS DE NOVO AND 80% STENOSED. THE 2ND STENT WAS A (B)(4), DEPLOYED AT 16ATM. THE STENT WAS POST-DILATED WITH A 3.5 X 15MM BALLOON AT 18ATM. POST-PROCEDURE STENOSIS WAS 0%. THE PATIENT REPORTED CHEST PAIN POST-PROCEDURE WHICH WAS MEDICALLY MANAGED ONLY. THE PATIENT WAS DISCHARGED 2 DAYS LATER. APPROXIMATELY 5 MONTHS POST-PROCEDURE, THE PATIENT REPORTED STABLE ANGINA. THREE WEEKS LATER, THE PATIENT REPORTED STABLE ANGINA AND HAD A DES STENT DEPLOYED IN THE MID RCA. APPROXIMATELY A YEAR POST-PROCEDURE, THE PATIENT REPORTED UNSTABLE ANGINA AND HAD A CABG TO TREAT THE MID RCA. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THESE LOTS PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. ANGINA IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING CORONARY STENTING PROCEDURES. THERE ARE PATIENT AND PROCEDURAL FACTORS WHICH MAY HAVE CONTRIBUTED TO THE EVENT. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THE PATIENT'S MEDICAL HISTORY OF CORONARY ARTERY DISEASE, DIABETES AND HYPERTENSION AND/OR LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE ANGINA AND THE RESTENOSIS. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    CLOPIDOGREL, CATAPRES, HYTRIN, METOPROLOL, NOVOLOG, PROTONIX, TRICOR, ZETIA, ZOCOR. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 003742446-2011-00381 AND 3003742446-2011-00382. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT IS FROM (B)(4) STUDY. THE INDICATION FOR AN INTERVENTION WAS STABLE ANGINA PECTORIS. THE TARGET LESION WAS THE MID RCA. VESSEL DIAMETER WAS 3MM AND THE LESION LENGTH WAS 50MM. THE VESSEL WAS MODERATELY TORTUOUS AND A LESION CLASSIFICATION A. THE LESION WAS AN IN-STENT RESTENOSIS OF A DES STENT AND 90% STENOSED. THE LESION WAS PRE-DILATED WITH 2 BALLOONS (2.5 X 15MM BALLOON) AT 15ATM. THE 1ST STENT DEPLOYED WAS A (B)(4) AT 15ATM. THE STENT WAS POST-DILATED WITH A 3 X 15MM BALLOON AT 15ATM. A (B)(4) DEPLOYED AT 15ATM, OVERLAPPING AND PROXIMAL TO THE 1ST STENT. THE 3RD STENT, A (B)(4), WAS DEPLOYED AT 14ATM, OVERLAPPING AND PROXIMAL TO THE PREVIOUS STENT. THE STENT WAS POST-DILATED WITH A 3 X 15MM BALLOON AT 15ATM. POST-PROCEDURE STENOSIS WAS 0%. THREE DAYS LATER, THE PATIENT HAD A PLANNED STAGED PROCEDURE DUE TO EXCESSIVE DYE. THE TARGET LESIONS WERE THE 2ND OM AND THE PROXIMAL CFX. THE 2ST OM WAS 3.5MM IN DIAMETER AND THE LESION WAS 24MMIN LENGTH. THE VESSEL WAS HEAVILY CALCIFIED AND A CLASSIFICATION B2. THE LESION WAS DE NOVO AND 80% STENOSED. THE LESION WAS PRE-DILATED WITH A 3.5 X 15MM BALLOON AT 18ATM. A (B)(4) WAS DEPLOYED AT 12ATM. THE PROX CFX WAS 3.5MM IN DIAMETER AND THE LESION WAS 26MM LONG. THE VESSEL WAS MODERATELY CALCIFIED AND A CLASSIFICATION B2. THE LESION WAS DE NOVO AND 80% STENOSED. THE 2ND STENT WAS A (B)(4), DEPLOYED AT 16ATM. THE STENT WAS POST-DILATED WITH A 3.5 X 15MM BALLOON AT 18ATM. POST-PROCEDURE STENOSIS WAS 0%. THE PATIENT REPORTED CHEST PAIN POST-PROCEDURE WHICH WAS MEDICALLY MANAGED ONLY. THE PATIENT WAS DISCHARGED 2 DAYS LATER. APPROXIMATELY 5 MONTHS POST-PROCEDURE, THE PATIENT REPORTED STABLE ANGINA. THREE WEEKS LATER, THE PATIENT REPORTED STABLE ANGINA AND HAD A DES STENT DEPLOYED IN THE MID RCA. APPROXIMATELY A YEAR POST-PROCEDURE, THE PATIENT REPORTED UNSTABLE ANGINA AND HAD A CABG TO TREAT THE MID RCA.

    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 15109831

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention MEDICATIONS: ASPIRIN