BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 3193801 · Received June 27, 2013

    Report

    Report Number
    3003742446-2013-00080
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    March 25, 2010
    Report Date
    June 5, 2013
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012, AT 23:28, THE CK WAS 50 WITH A CKMB OF 3.7 AND THE TROPONIN OF 0.65. ON (B)(6) 2012, AT 09:55, THE CK WAS 54 WITH A CKMB OF 3.5 AND THE TROPONIN OF 0.04. THE ECG CORE LAB REPORTED NO NEW MAJOR ST-T ABNORMALITIES AND NO NEW Q WAVES. THE SITE REPORTED NO POST-PROCEDURE COMPLICATIONS. THE PATIENT WAS DISCHARGED ON A DAY LATER ON DUAL ANTIPLATELET THERAPY. ADJUDICATION MINUTES CONSIDERED THE ELEVATION IN ENZYMES AS A PERIPROCEDURAL MI RELATED TO STUDY DEVICES. CONCOMITANT MEDICATIONS INCLUDED ASPIRIN, CARISOPRODOL, PLAVIX, DILTIAZEM, HEPARIN, IMDUR, AND METOPROLOL. THE REPORT RECEIVED FROM THE (B)(4) ADJUDICATION MINUTES INDICATED THAT THE PATIENT EXPERIENCED PERIPROCEDURAL MYOCARDIAL INFARCTION POST STAGED PROCEDURE. THE PATIENT IS A (B)(6) WOMAN WITH A HISTORY OF HYPERTENSION, DYSLIPIDEMIA AND EF OF 40-50%, WHO PRESENTED WITH BRAUNWALD CLASS III ANGINA, A 75% STENOSIS IN THE PROXIMAL LAD. THE SITE ALSO REPORTED A 95% STENOSIS IN THE 1ST OM AND A 95% STENOSIS IN THE 2ND OM. AT THE TIME OF INDEX PROCEDURE, PATIENT UNDERWENT PRE-STENT BALLOON ANGIOPLASTY AND PLACEMENT OF A 3X23MM CYPHER STENT (# 15079013) IN THE PLAD. THE PLAD LESION WAS DESCRIBED AS 18MM IN LENGTH, CLASS A, MILDLY CALCIFIED, AND DE NOVO WITH 75% STENOSIS. THE ANGIOGRAPHIC CORE LAB REPORTED A 20% FINAL RESIDUAL IN-LESION STENOSIS WITH NO DISSECTION AND TIMI 3 FLOW. THE POST-PROCEDURE COURSE WAS UNCOMPLICATED AND THE PATIENT WAS DISCHARGED A DAY LATER ON DUAL ANTIPLATELET THERAPY. AFTER TWO WEEKS, PATIENT UNDERWENT SCHEDULED STAGED PROCEDURE FOR TREATMENT OF 1OM AND 2OM. THE LESION IN THE 1OM WAS DESCRIBED AS 15MM IN LENGTH, MODERATELY CALCIFIED, MILDLY TORTUOUS, CLASS B1, AND DE NOVO WITH 95% STENOSIS. THE REFERENCE VESSEL WAS 2.25MM IN DIAMETER. A 2.25X18MM CYPHER STENT (#15075551) WAS IMPLANTED AT 16ATMS. THE SITE REPORTED A 0% FINAL RESIDUAL IN-LESION STENOSIS WITH NO DISSECTION AND TIMI 3 FLOW. THE SECOND LESION WAS IN THE 2OM DESCRIBED AS 15MM IN LENGTH, MILDLY CALCIFIED, MODERATELY TORTUOUS, CLASS B1, AND DE NOVO WITH 95% STENOSIS. THE REFERENCE VESSEL WAS 2.25MM IN DIAMETER. A 2.25X18MM CYPHER STENT (# 15075551) WAS IMPLANTED AT 16ATMS. THE SITE REPORTED A 0% FINAL RESIDUAL IN-LESION STENOSIS WITH NO DISSECTION AND TIMI 3 FLOW. THE PROCEDURE WAS UNCOMPLICATED. THE INITIAL STUDY STENT PLACED IN THE LAD WAS WIDELY PATENT ACCORDING TO THE SITE. PRE-STAGED PROCEDURE, ON (B)(6) 2012, AT 13:53, THE CK WAS 33 (NL 215) WITH A CKMB OF 0.4 (NL 3.6) AND THE TROPONIN <0.04 (NL 0.07). ON (B)(6) 2012, AT 23:28, THE CK WAS 50 WITH A CKMB OF 3.7 AND THE TROPONIN OF 0.65. ON (B)(6) 2012, AT 09:55, THE CK WAS 54 WITH A CKMB OF 3.5 AND THE TROPONIN OF 0.04. THE ECG CORE LAB REPORTED NO NEW MAJOR ST-T ABNORMALITIES AND NO NEW Q WAVES. THE SITE REPORTED NO POST-PROCEDURE COMPLICATIONS. THE PATIENT WAS DISCHARGED ON A DAY LATER ON DUAL ANTIPLATELET THERAPY. ADJUDICATION MINUTES CONSIDERED THE ELEVATION IN ENZYMES AS A PERIPROCEDURAL MI RELATED TO STUDY DEVICES. 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. MYOCARDIAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF ANGIOPLASTY/STENT IMPLANTATION INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY SLOWING OR COMPLETELY OCCLUDING THE BLOOD FLOW. THE INFLATION OF CORONARY DEVICES ALSO INHERENTLY OCCLUDES THE DISTAL BLOOD FLOW, POSSIBLY CREATING ISCHEMIC AREAS (CAUSING CARDIAC ENZYME CHANGES) DISTAL TO THE TARGET LESION. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE PATIENT¿S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2013-00080 AND 3003742446-2013-00081.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) ADJUDICATION MINUTES INDICATED THAT THE PATIENT EXPERIENCED PERIPROCEDURAL MYOCARDIAL INFARCTION POST STAGED PROCEDURE. THE PATIENT IS A (B)(6) WOMAN WITH A HISTORY OF HYPERTENSION, DYSLIPIDEMIA AND EF OF 40-50%, WHO PRESENTED WITH BRAUNWALD CLASS III ANGINA, A 75% STENOSIS IN THE PROXIMAL LAD. THE SITE ALSO REPORTED A 95% STENOSIS IN THE 1ST OM AND A 95% STENOSIS IN THE 2ND OM. AT THE TIME OF INDEX PROCEDURE, PATIENT UNDERWENT PRE-STENT BALLOON ANGIOPLASTY AND PLACEMENT OF A 3X23MM CYPHER STENT (# 15079013) IN THE PLAD. THE PLAD LESION WAS DESCRIBED AS 18MM IN LENGTH, CLASS A, MILDLY CALCIFIED, AND DE NOVO WITH 75% STENOSIS. THE ANGIOGRAPHIC CORE LAB REPORTED A 20% FINAL RESIDUAL IN-LESION STENOSIS WITH NO DISSECTION AND TIMI 3 FLOW. THE POST-PROCEDURE COURSE WAS UNCOMPLICATED AND THE PATIENT WAS DISCHARGED A DAY LATER ON DUAL ANTIPLATELET THERAPY. AFTER TWO WEEKS, PATIENT UNDERWENT SCHEDULED STAGED PROCEDURE FOR TREATMENT OF 1OM AND 2OM. THE LESION IN THE 1OM WAS DESCRIBED AS 15MM IN LENGTH, MODERATELY CALCIFIED, MILDLY TORTUOUS, CLASS B1, AND DE NOVO WITH 95% STENOSIS. THE REFERENCE VESSEL WAS 2.25MM IN DIAMETER. A 2.25X18MM CYPHER STENT (#15075551) WAS IMPLANTED AT 16ATMS. THE SITE REPORTED A 0% FINAL RESIDUAL IN-LESION STENOSIS WITH NO DISSECTION AND TIMI 3 FLOW. THE SECOND LESION WAS IN THE 2OM DESCRIBED AS 15MM IN LENGTH, MILDLY CALCIFIED, MODERATELY TORTUOUS, CLASS B1, AND DE NOVO WITH 95% STENOSIS. THE REFERENCE VESSEL WAS 2.25MM IN DIAMETER. A 2.25X18MM CYPHER STENT (# 15075551) WAS IMPLANTED AT 16ATMS. THE SITE REPORTED A 0% FINAL RESIDUAL IN-LESION STENOSIS WITH NO DISSECTION AND TIMI 3 FLOW. THE PROCEDURE WAS UNCOMPLICATED. THE INITIAL STUDY STENT PLACED IN THE LAD WAS WIDELY PATENT ACCORDING TO THE SITE. PRE-STAGED PROCEDURE, ON (B)(6) 2012, AT 13:53, THE CK WAS 33 (NL 215) WITH A CKMB OF 0.4 (NL 3.6) AND THE TROPONIN <0.04 (NL 0.07).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292314 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15075551

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening