BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2620690 · Received June 19, 2012

    Report

    Report Number
    3003742446-2012-00401
    Event Type
    Injury
    Date Received
    June 19, 2012
    Date of Event
    April 14, 2010
    Report Date
    May 22, 2012
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED FROM THE CEC ADJUDICATION MINUTES OF A (B)(4) STUDY, A PATIENT EXPERIENCED PERIPROCEDURAL MYOCARDIAL INFARCTION POST INDEX PROCEDURE. AS PER THE CRF, THE PATIENT HAD A PREVIOUS HISTORY OF PCI IN THE LAD APPROXIMATELY (B)(6) BEFORE THE INDEX PROCEDURE. IT WAS REPORTED THAT TWO CYPHER STENTS WITH LOT NUMBER #15096801 AND #15093159 WERE IMPLANTED IN THE LAD. AT THE TIME OF INDEX PROCEDURE, THE ANGIOGRAPHY REVEALED TWO VESSELS DISEASED. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA PECTORIS. THE FIRST LESION TREATED WAS DISTAL CIRCUMFLEX THAT WAS DESCRIBED AS 13 MM IN LENGTH, CLASS A, AND DE NOVO WITH 70% STENOSIS. THE REFERENCE VESSEL WAS 3 MM IN DIAMETER. AS PLANNED, THE LESION WAS PRE-DILATED WITH A 2.5 X 15 MM BALLOON AT 6 ATM AND A 3 X 13 MM CYPHER RX WAS IMPLANTED AT 14 ATM. THERE WAS NO POST-DILATION CONDUCTED FOR THIS STENT. THE SECOND LESION TREATED WAS PROXIMAL CIRCUMFLEX THAT WAS DESCRIBED AS 13 MM IN LENGTH, CLASS B1, AND DE NOVO WITH 95% STENOSIS. THE REFERENCE VESSEL WAS 3 MM IN DIAMETER. AS PLANNED, THE LESION WAS PRE-DILATED WITH A 2.5 X 15 MM BALLOON AT 6 ATM AND A 3 X 13 MM CYPHER RX WAS IMPLANTED AT 17 ATM. THE STENT WAS NOT POST-DILATED. PREVIOUSLY PLACED TWO CYPHER STENTS AT THE TIME OF PREVIOUS PCI WERE NOTED TO BE WIDELY PATENT AT THE TIME OF INDEX PROCEDURE AND THERE WERE NO ISSUES REPORTED WITH PREVIOUS TWO CYPHER STENTS SINCE BOTH WERE IMPLANTED IN THE LAD AND THE INDEX WAS PERFORMED IN THE PROXIMAL CX AND DISTAL CX. THE PATIENT'S CARDIAC ENZYMES WERE REPORTED TO BE NORMAL AT SCREENING. BUT THE CK-MB WAS 8.2 (5.0 UNL) AND THE TROPONIN I WAS 0.34 (0.04 UNL) AT 6-12 HOURS POST INDEX PROCEDURE; AND THE CK WAS 254 (200 UNL), THE CK-MB WAS 22, AND THE TROPONIN I WAS 1.79 AT 16-24 HOURS POST INDEX PROCEDURE. AS PER THE ADJUDICATION MINUTES, THE ECG CORE LAB REPORTED NO NEW ST-T ABNORMALITIES AND NO NEW Q WAVES, BUT THE ELEVATION IN ENZYMES WAS LATER DIAGNOSED AS A PERIPROCEDURAL MYOCARDIAL INFARCTION BASED ON THE RECEIVED ADJUDICATION MINUTES. THE CYPHER STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. 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. REVIEW OF LOT 15107475 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. MYOCARDIAL INFARCTION IS 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 3003742446-2012-00400 AND 3003742446-2012-00401.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS AT THE TIME OF MI INCLUDED ASPIRIN, BIVALIRUDIN, PLAVIX, COREG, LIPITOR, AND LISINOPRIL. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2012-00400 AND 3003742446-2012-00401.

    Description of Event or Problem · 1

    AS REPORTED FROM THE CEC ADJUDICATION MINUTES OF A (B)(4) STUDY, A PATIENT EXPERIENCED PERIPROCEDURAL MYOCARDIAL INFARCTION POST INDEX PROCEDURE. AS PER THE CRF, THE PATIENT HAD A PREVIOUS HISTORY OF PCI IN THE LAD APPROXIMATELY A MONTH BEFORE THE INDEX PROCEDURE. IT WAS REPORTED THAT TWO CYPHER STENTS WITH LOT NUMBER #15096801 AND #15093159 WERE IMPLANTED IN THE LAD. AT THE TIME OF INDEX PROCEDURE, THE ANGIOGRAPHY REVEALED TWO VESSELS DISEASED. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA PECTORIS. THE FIRST LESION TREATED WAS DISTAL CIRCUMFLEX THAT WAS DESCRIBED AS 13MM IN LENGTH, CLASS A, AND DE NOVO WITH 70% STENOSIS. THE REFERENCE VESSEL WAS 3MM IN DIAMETER. AS PLANNED, THE LESION WAS PRE-DILATED WITH A 2.5 X 15MM BALLOON AT 6ATM AND A 3 X 13MM CYPHER RX WAS IMPLANTED AT 14ATM. THERE WAS NO POST-DILATION CONDUCTED FOR THIS STENT. THE SECOND LESION TREATED WAS PROXIMAL CIRCUMFLEX THAT WAS DESCRIBED AS 13MM IN LENGTH, CLASS B1, AND DE NOVO WITH 95% STENOSIS. THE REFERENCE VESSEL WAS 3MM IN DIAMETER. AS PLANNED, THE LESION WAS PRE-DILATED WITH A 2.5 X 15MM BALLOON AT 6ATM AND A 3 X 13MM CYPHER RX WAS IMPLANTED AT 17ATM. THE STENT WAS NOT POST-DILATED. PREVIOUSLY PLACED TWO CYPHER STENTS AT THE TIME OF PREVIOUS PCI WERE NOTED TO BE WIDELY PATENT AT THE TIME OF INDEX PROCEDURE AND THERE WERE NO ISSUES REPORTED WITH PREVIOUS TWO CYPHER STENTS SINCE BOTH WERE IMPLANTED IN THE LAD AND THE INDEX WAS PERFORMED IN THE PCX AND DCX. THE PATIENT'S CARDIAC ENZYMES WERE REPORTED TO BE NORMAL AT SCREENING. BUT THE CK-MB WAS 8.2 (5.0 UNL) AND THE TROPONIN I WAS 0.34 (0.04 UNL) AT 6-12 HOURS POST INDEX PROCEDURE; AND THE CK WAS 254 (200 UNL), THE CK-MB WAS 22, AND THE TROPONIN I WAS 1.79 AT 16-24 HOURS POST INDEX PROCEDURE. AS PER THE ADJUDICATION MINUTES, THE ECG CORE LAB REPORTED NO NEW ST-T ABNORMALITIES AND NO NEW Q WAVES, BUT THE ELEVATION IN ENZYMES WAS LATER DIAGNOSED AS A PERIPROCEDURAL MYOCARDIAL INFARCTION BASED ON THE RECEIVED ADJUDICATION MINUTES.

    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 15107475

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening