BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2002871 · Received February 28, 2011

    Report

    Report Number
    3003742446-2011-00111
    Event Type
    Death
    Date Received
    February 28, 2011
    Date of Event
    December 21, 2010
    Report Date
    October 11, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATELY ELEVEN MONTHS POST IMPLANTATION OF SIX CYPHER RX STENTS THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS LISTED AS CARDIAC ARREST (POSSIBLE ACUTE MYOCARDIAL INFARCTION). AT INDEX PROCEDURE THE PATIENT WAS ADMITTED FOR UNSTABLE ANGINA PECTORIS, POSITIVE FUNCTIONAL TEST FOR ISCHEMIA AND CHF AND UNCONTROLLED HYPERTENSION. THE TARGET LESIONS WERE THE FIRST OBTUSE MARGINAL (OM1) AND THE POSTERIOR DESCENDING ARTERY (PDA). THE PATIENT HAD 99% STENOSIS OF THE FIRST OM1. THE LESION WAS DESCRIBED AS 80MM IN LENGTH AND DE NOVO. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. PRIOR TO STENT IMPLANTATION, PRE-DILATION WAS PERFORMED WITH A FIRESTAR BALLOON. A 2.25 X 23 CYPHER RX STENT WAS THEN IMPLANTED AT THE TARGET LESION AT 12ATM. A SECOND 2.5 X 28 CYPHER RX STENT WAS THEN IMPLANTED PROXIMAL TO THE FIRST STENT AT 12ATM, BUT THIS STENT WAS NOT PLACED IN THE INTENDED SITE AND DID NOT OVERLAP AS INTENDED PROXIMAL TO THE FIRST. AFTER THE SECOND STENT WAS DEPLOYED AND ANGIOGRAPHY WAS PERFORMED THE SECOND STENT WAS FOUND TO BE 4-5 MM SHORT OF THE FIRST STENT, NECESSITATING PLACING ANOTHER STENT IN BETWEEN THE FIRST TWO STENTS TO CLOSE THE GAP. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THERE WAS NO POSITIONING PROBLEM EXPERIENCED. THERE WAS NO DIFFICULTY OR RESISTANCE DURING DEPLOYMENT. A THIRD 2.5 X 8 CYPHER RX STENT WAS THEN OVERLAPPED AT 14ATM BETWEEN THE FIRST AND THE SECOND STENT TO COVER A GAP BETWEEN THE TWO. A FOURTH 3.5 X 23 CYPHER RX STENT WAS THEN IMPLANTED PROXIMAL TO THE FIRST STENT AT 12ATM. ALL FOUR STENTS WERE POST-DILATED AS PART OF STANDARD PROCEDURE. POST PROCEDURE STENOSIS WAS 0%. THE SECOND TARGET LESION WAS A 95% STENOSIS OF THE PDA. THE LESION WAS DESCRIBED AS 48MM IN LENGTH, DE NOVO AND ANATOMICALLY COMPLEX. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. A 2.25 X 23 AND 2.5 X 23 CYPHER RX STENT WERE OVERLAPPED TO FULLY COVER THE LESION AFTER PRE-DILATION. POST PROCEDURE STENOSIS WAS 0%. BOTH STENTS WERE POST-DILATED AS PART OF STANDARD PROCEDURE. THE PATIENT WAS DISCHARGED THE TWO DAY POST INDEX PROCEDURE WITHOUT ANY INDICATION OF ANGINA. ADDITIONAL MEDICAL HISTORY INCLUDED HYPERLIPIDEMIA, HYPERTENSION, LVEF NORMAL (> 50%), CONGESTIVE HEART FAILURE, DIABETES MELLITUS TYPE I, SMOKING (WITHIN 30 DAYS), ANEMIA, GI AV MALFORMATION AND MILD RENAL ARTERY STENOSIS, AND STROKE. APPROXIMATELY ELEVEN MONTHS POST-PROCEDURE THE PATIENT EXPIRED. THE PATIENT DIED FROM CARDIAC ARREST. IT IS UNKNOWN IF THERE WAS ANY RESTENOSIS OR THROMBOSIS OF THE CORDIS STENTS. ALTHOUGH THERE WAS NO DIAGNOSIS OF MYOCARDIAL INFARCTION (MI), IT WAS REPORTED THAT THIS WAS BELIEVED TO BE THE POSSIBLE CAUSE. THERE WAS NO DEFINITE MI. NO FURTHER ANGIOGRAPHY WAS PERFORMED POST STENT IMPLANTATION. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. MYOCARDIAL EVENTS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH PLACEMENT OF CORONARY ARTERY STENTS. BASED ON THE AVAILABLE INFORMATION NO CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE EVENTS AND CYPHER STENT IMPLANTED AT INDEX PROCEDURE. THIS PATIENT'S EXTENSIVE MEDICAL HISTORY PUT HER AT AN INCREASED RISK FOR MACE. THE STENTS REMAIN IMPLANTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THE LOTS OF IMPLANTED STENTS PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF SIX PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 3003742446-2010-00400, 3003742446-2011-00111, 3003742446-2011-00112, 3003742446-2011-00113, 3003742446-2011-00114, AND 3003742446-2011-00115.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM THE ADJUDICATION COMMITTEE FOR THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED A MYOCARDIAL INFARCTION, STENT THROMBOSIS AND DIED AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. AT INDEX PROCEDURE THE PATIENT WAS ADMITTED FOR UNSTABLE ANGINA PECTORIS, POSITIVE FUNCTIONAL TEST FOR ISCHEMIA AND CHF AND UNCONTROLLED HYPERTENSION. THE TARGET LESIONS WERE THE FIRST OBTUSE MARGINAL (OM1) AND THE POSTERIOR DESCENDING ARTERY (PDA). THE PATIENT HAD 99% STENOSIS OF THE FIRST OM1. THE LESION WAS DESCRIBED AS 80MM IN LENGTH AND DE NOVO. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. PRIOR TO STENT IMPLANTATION, PRE-DILATION WAS PERFORMED WITH A FIRESTAR BALLOON. A 2.25 X 23 CYPHER RX STENT WAS THEN IMPLANTED AT THE TARGET LESION AT 12ATM. A SECOND 2.5 X 28 CYPHER RX STENT WAS THEN IMPLANTED PROXIMAL TO THE FIRST STENT AT 12ATM, BUT THIS STENT WAS NOT PLACED IN THE INTENDED SITE AND DID NOT OVERLAP AS INTENDED PROXIMAL TO THE FIRST. AFTER THE SECOND STENT WAS DEPLOYED AND ANGIOGRAPHY WAS PERFORMED THE SECOND STENT WAS FOUND TO BE 4-5 MM SHORT OF THE FIRST STENT, NECESSITATING PLACING ANOTHER STENT IN BETWEEN THE FIRST TWO STENTS TO CLOSE THE GAP. THERE WAS NO POSITIONING PROBLEM EXPERIENCED. THERE WAS NO DIFFICULTY OR RESISTANCE DURING DEPLOYMENT. A THIRD 2.5 X 8 CYPHER RX STENT WAS THEN OVERLAPPED AT 14ATM BETWEEN THE FIRST AND THE SECOND STENT TO COVER A GAP BETWEEN THE TWO. A FOURTH 3.5 X 23 CYPHER RX STENT WAS THEN IMPLANTED PROXIMAL TO THE FIRST STENT AT 12ATM. ALL FOUR STENTS WERE POST-DILATED AS PART OF STANDARD PROCEDURE. POST PROCEDURE STENOSIS WAS 0%. THE SECOND TARGET LESION WAS A 95% STENOSIS OF THE PDA. THE LESION WAS DESCRIBED AS 48MM IN LENGTH, DE NOVO AND ANATOMICALLY COMPLEX. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. A 2.25 X 23 AND 2.5 X 23 CYPHER RX STENT WERE OVERLAPPED TO FULLY COVER THE LESION AFTER PRE-DILATION. POST PROCEDURE STENOSIS WAS 0%. BOTH STENTS WERE POST-DILATED AS PART OF STANDARD PROCEDURE. THE PATIENT WAS DISCHARGED THE TWO DAY POST INDEX PROCEDURE WITHOUT ANY INDICATION OF ANGINA. ADDITIONAL MEDICAL HISTORY INCLUDED HYPERLIPIDEMIA, HYPERTENSION, LVEF NORMAL (> 50%), CONGESTIVE HEART FAILURE, DIABETES MELLITUS TYPE I, SMOKING (WITHIN 30 DAYS), ANEMIA, GI AV MALFORMATION AND MILD RENAL ARTERY STENOSIS, AND STROKE. APPROXIMATELY ELEVEN MONTHS POST-PROCEDURE THE PATIENT EXPIRED. THE PATIENT DIED FROM CARDIAC ARREST. THE CEC COMMITTEE HAS ADJUDICATED THAT, BECAUSE THERE IS NO EVIDENCE TO DISCOUNT AN MI OR A THROMBOTIC EVENT, THERE IS A POSSIBILITY THAT THESE EVENTS MAY HAVE OCCURRED AND CONTRIBUTED TO THE PATIENT'S DEATH. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. MYOCARDIAL INFARCTION, STENT THROMBOSIS AND DEATH ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH PLACEMENT OF CORONARY ARTERY STENTS. BASED ON THE AVAILABLE INFORMATION NO CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE EVENTS AND CYPHER STENT IMPLANTED AT INDEX PROCEDURE. THIS PATIENT'S EXTENSIVE MEDICAL HISTORY PUT HER AT AN INCREASED RISK FOR MACE. THERE IS NO EVIDENCE OF A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF SIX PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 3003742446-2010-00400, 3003742446-2011-00111, 3003742446-2011-00112, 3003742446-2011-00113, 3003742446-2011-00114, AND 3003742446-2011-00115.

    Additional Manufacturer Narrative · 1

    A THIRD 2.5 X 8 CYPHER RX STENT WAS THEN OVERLAPPED AT 14ATM BETWEEN THE FIRST AND THE SECOND STENT TO COVER A GAP BETWEEN THE TWO. A FOURTH 3.5 X 23 CYPHER RX STENT WAS THEN IMPLANTED PROXIMAL TO THE FIRST STENT AT 12ATM. ALL FOUR STENTS WERE POST-DILATED AS PART OF STANDARD PROCEDURE. POST PROCEDURE STENOSIS WAS 0%. THE SECOND TARGET LESION WAS THE PDA. THE PATIENT HAD 95% STENOSIS OF THE FIRST OM1. THE LESION WAS DESCRIBED AS 48MM IN LENGTH, DE NOVO AND ANATOMICALLY COMPLEX. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. A 2.25 X 23 AND 2.5 X 23 CYPHER RX STENT WERE OVERLAPPED TO FULLY COVER THE LESION AFTER PREDILATION. POST PROCEDURE STENOSIS WAS 0%. BOTH STENTS WERE POST-DILATED AS PART OF STANDARD PROCEDURE. THE PATIENT WAS DISCHARGED THE TWO DAY POST INDEX PROCEDURE WITHOUT ANY INDICATION OF ANGINA. APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE THE PATIENT EXPERIENCED CONFUSION, LEFT SIDED WEAKNESS, SLURRED SPEECH AND VISUAL FIELD CUTS. THE DIAGNOSIS WAS A STROKE (CVA/TIA). THE STROKE RESOLVED WITH SEQUELAE AFTER FOUR DAYS AND WAS MEDICALLY MANAGED. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF SIX PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 3003742446-2010-00400, 3003742446-2011-00111, 3003742446-2011-00112, 3003742446-2011-00113, 3003742446-2011-00114, AND 3003742446-2011-00115.

    Additional Manufacturer Narrative · 1

    THE CEC ADJUDICATION MINUTES WERE RECEIVED AND REVIEWED. THE ADJUDICATION HAS DETERMINED THAT THE POST-PROCEDURE ELEVATED ENZYMES ARE AN ARC (PERI-PROCEDURAL PCI) DEFINED AS A MYOCARDIAL INFARCTION (MI). THE ADJUDICATION HAS AGREED WITH THE DETERMINATION OF CARDIAC DEATH RELATED TO DAPT. THE ADJUDICATION HAS ALSO NOW INDICATED AN EVENT OF LATE STENT THROMBOSIS WHICH OCCURRED APPROXIMATELY TEN MONTHS POST INDEX PROCEDURE. THE EVENT WAS DETERMINED TO BE RELATED TO THE STUDY (B)(4) DEVICES. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF SIX PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 3003742446-2010-00400, 3003742446-2011-00111, 3003742446-2011-00112, 3003742446-2011-00113, 3003742446-2011-00114, AND 3003742446-2011-00115.

    Description of Event or Problem · 1

    APPROXIMATELY ELEVEN MONTHS POST PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS LISTED AS CARDIAC ARREST (POSSIBLE ACUTE MYOCARDIAL INFARCTION). THE PATIENT WAS ADMITTED FOR UNSTABLE ANGINA PECTORIS, POSITIVE FUNCTIONAL TEST FOR ISCHEMIA AND CHF AND UNCONTROLLED HYPERTENSION. THE TARGET LESIONS WERE THE FIRST OBTUSE MARGINAL (OM1) AND THE POSTERIOR DESCENDING ARTERY (PDA). THE PATIENT HAD 99% STENOSIS OF THE FIRST OM1. THE LESION WAS DESCRIBED AS 80MM IN LENGTH AND DE NOVO. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. PRIOR TO STENT IMPLANTATION, PRE-DILATION WAS PERFORMED WITH A FIRESTAR BALLOON. A 2.25 X 23 CYPHER RX STENT WAS THEN IMPLANTED AT THE TARGET LESION AT 12ATM. A SECOND 2.5 X 28 CYPHER RX STENT WAS THEN IMPLANTED PROXIMAL TO THE FIRST STENT AT 12ATM, BUT THIS STENT WAS NOT PLACED IN THE INTENDED SITE AND DID NOT OVERLAP AS INTENDED PROXIMAL TO THE FIRST. AFTER THE SECOND STENT WAS DEPLOYED AND ANGIOGRAPHY WAS PERFORMED THE SECOND STENT WAS FOUND TO BE 4-5 MM SHORT OF THE FIRST STENT, NECESSITATING PLACING ANOTHER STENT IN BETWEEN THE FIRST TWO STENTS TO CLOSE THE GAP. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THERE WAS NO POSITIONING PROBLEM EXPERIENCED. THERE WAS NO DIFFICULTY OR RESISTANCE DURING DEPLOYMENT.

    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 15079015

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death BOSTON SCIENTIFIC ENCORE 26 INFLATION DEVICE