BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2142539 · Received June 28, 2011

    Report

    Report Number
    3003742446-2011-00340
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    January 26, 2010
    Report Date
    June 11, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS INCLUDED: ROSUVASTATIN 20M DAILY, (B)(6) 2009, CONTINUING, ESCITALOPRAM 20MG DAILY, 2008, CONTINUING, METOPROLOL 50MG DAILY, (B)(6) 2009 TO (B)(6) 2010, MULTIVITAMIN DAILY SINCE 1990, VITAMIN C DAILY SINCE 1990, ASPIRIN 325MG DAILY, (B)(6) 2009, CONTINUING, CLOPIDOGREL 75MG DAILY, (B)(6) 2009, CONTINUING. 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 3003742446-2011-00340 AND 3003742446-2010-00224.

    Additional Manufacturer Narrative · 1

    UPDATED COMPLAINT CONCLUSION: INFORMATION RECEIVED FROM (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED A PERI-PROCEDURAL MYOCARDIAL INFARCTION (PROVIDED BY (B)(6)) AND UNDERWENT PERCUTANEOUS REVASCULARIZATION AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PATIENT'S RELEVANT MEDICAL HISTORY IS SIGNIFICANT FOR PREVIOUS PCI OF A NON-TARGET VESSEL, ANGINA, AND FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA AND A SMOKING. THE INDICATION FOR THE INDEX PROCEDURE WAS ANGINA WITH A POSITIVE FUNCTIONAL STRESS TEST. THE TARGET LESION WAS THE DISTAL AND PROXIMAL CIRCUMFLEX ARTERY (CFX). THE DISTAL CFX WAS DESCRIBED AS DE NOVO AND 100% OCCLUDED. THE LESION WAS PRE-DILATED FOLLOWED BY THE IMPLANT OF A 2.5MM X 28MM CYPHER STENT AT 18ATMS WITH NO RESIDUAL STENOSIS. THE STENT WAS NOT POST-DILATED. THE PROXIMAL CFX WAS DESCRIBED AS 75% STENOSED AND DE NOVO. THE LESION WAS PRE-DILATED FOLLOWED BY THE IMPLANT OF A 2.5MM X 18MM CYPHER STENT AT 18ATMS WITHOUT POST-DILATION. THE REPORTED RESIDUAL STENOSIS WAS 0%. THE SITE REPORTED THAT THE POST-PROCEDURE ENZYMES WERE ELEVATED THE DAY AFTER THE PROCEDURE, WITH THE TROPONIN I AT 0.19 (RATIO 3.8) AT ITS HIGHEST LEVEL. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. APPROXIMATELY FOUR AND A HALF MONTHS LATER, THE PATIENT HAD REPEAT ANGIOGRAPHY DUE TO ANGINA AND A POSITIVE STRESS TEST. THE ANGIOGRAM REVEALED A 95% STENOSIS IN THE PROXIMAL CFX, PROXIMAL TO THE PREVIOUSLY IMPLANTED CYPHER. THE LESION WAS TREATED WITH THE IMPLANT OF A 28MM XIENCE STENT AND THE REPORTED RESIDUAL STENOSIS WAS 0%. THE PATIENT ALSO HAD A XIENCE STENT PLACED IN THE OSTIUM OF THE RIGHT CORONARY ARTERY AND WAS DISCHARGED THE FOLLOWING DAY. ACCORDING TO THE INVESTIGATOR, THE RESTENOSIS WAS PROBABLY RELATED TO THE CYPHER STENT. STENT WAS IMPLANTED, THEREFORE, NOT AVAILABLE 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. MYOCARDIAL INFARCTION AS EVIDENCED BY ELEVATED CARDIAC ENZYMES IS A COMMON RESULT OF IMPLANTING CORONARY ARTERY STENTS. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, WHICH LEADS TO DAMAGED HEART CELLS AND THE RELEASE OF CARDIAC BIOMARKER ENZYMES INTO THE SYSTEMIC BLOODSTREAM. THIS ACTION (INHERENT RISK OF THE PROCEDURE) 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 PATIENT FACTORS (SMOKING) AND THE NATURAL PROGRESSION OF CORONARY ARTERY DISEASE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00340 AND 3003742446-2010-00224.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(4) STUDY, THE INDICATION FOR THE INDEX PROCEDURE HAD BEEN STABLE ANGINA PECTORIS, POSITIVE FUNCTIONAL TEST FOR ISCHEMIA, AND A POSITIVE EKG. ANGIOGRAPHY REVEALED STENOSIS IN THE DISTAL AND PROXIMAL CIRCUMFLEX. THE DISTAL CIRCUMFLEX WAS 100% OCCLUDED WITH TIMI FLOW 0. THE LESION WAS 25MM IN LENGTH AND DENOVO WITH NO THROMBUS PRESENT. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. THE LESION WAS PRE-DILATED WITH A 2 X 20MM BALLOON AT 12ATM. A 2.5 X 28MM CYPHER WAS IMPLANTED AT 18ATM WITH NO RESIDUAL STENOSIS AND TIMI FLOW 3. THE STENT WAS NOT POST-DILATED. THE PROXIMAL CIRCUMFLEX LESION WAS 75% STENOSED AND 15MM IN LENGTH, WITHOUT THROMBUS. THE REFERENCE VESSEL WAS 2.7MM IN LENGTH. THE LESION WAS PRE-DILATED WITH A 3.0 X 20MM BALLOON AT 18ATM. A 2.5 X 18MM CYPHER WAS IMPLANTED AT THE TARGET LESION AT 18ATM OVERLAPPING THE INITIAL STENT WITHOUT POST-DILATION. THERE WAS GOOD WALL APPOSITION AND RESIDUAL STENOSIS WAS 0% AND TIMI FLOW WAS 3. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THE CEC MINUTES WERE RECEIVED 6/6/2011. THE ADJUDICATION COMMITTEE CONCLUDED THAT THE PATIENT EXPERIENCED PERI-PROCEDURE MYOCARDIAL INFARCTION THE DAY AFTER THE INDEX PROCEDURE, RELATED TO THE DEVICE AND THE PROCEDURE BASED ON ELEVATED TROPONIN I LEVELS AFTER THE PROCEDURE. PRE-PROCEDURE CARDIAC ENZYMES WERE WITHIN NORMAL LIMITS. TROPONIN I LEVEL PEAKED APPROXIMATELY 16 HOURS POST PROCEDURE AT 0.19 (ULN 0.05). CK AND CKMB REMAINED WITHIN NORMAL LIMITS. THE ECG CORE LAB REPORTED NO NEW MAJOR ST-T ABNORMALITIES AND NO Q WAVES AND THE POST-PROCEDURE COURSE WAS REPORTED TO BE UNCOMPLICATED. THE PATIENT WAS DISCHARGED LATER THAT 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 15048924

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening