BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1920193 · Received December 10, 2010

    Report

    Report Number
    3003742446-2010-00446
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 19, 2010
    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

    ELEVATED CARDIAC ENZYMES > 3 TIMES UPPER LIMIT OF NORMAL.TOPROL XL 50MG DAILY, (B)(6) 2009, CONTINUING,MEVACOR 80MG DAILY (B)(6) 2006, CONTINUING,BIVALIRUDIN INTRA-PROCEDURE (DOSE UNKNOWN).CLOPIDOGREL PRE-PROCEDURE (DOSE UNKNOWN).ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2010-00446, 3003742446-2010-00447 AND 3003742446-2010-00448.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 4/28/2011 FROM THE CEC ADJUDICATION MINUTES. IT WAS DETERMINED THAT THE ELEVATION IN CARDIAC ENZYMES MET THE CRITERIA FOR MYOCARDIAL INFARCTION. UPDATED COMPLAINT CONCLUSION: INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THIS EVENT WAS INITIALLY REPORTED AS ELEVATED CARDIAC ENZYMES, BUT HAS BEEN ADJUDICATED TO BE A MI. THE PATIENT'S HISTORY IS SIGNIFICANT FOR ANGINA, TARGET VESSEL PERCUTANEOUS CORONARY INTERVENTION AND STENTING (1999), HYPERLIPIDEMIA, HYPERTENSION, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HISTORY OF MYOCARDIAL INFARCTION ((B)(6) 1990), HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), VENTRICULAR TACHYCARDIA WITH ICD PLACEMENT AND SMOKING. AT THE TIME OF THE INDEX PROCEDURE, TWO LESIONS WERE TREATED. THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA. THE MID LEFT ANTERIOR DESCENDING (LAD) LESION WAS 34MM IN LENGTH AND DE NOVO WITH 90% STENOSIS. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER. THE LESION WAS PRE-DILATED WITH A 2.5 X 30MM BALLOON AT 12ATM. A 3.0 X 28MM CYPHER RX STENT WAS IMPLANTED AT 12ATM, AND A 3.0 X 18MM CYPHER RX STENT WAS IMPLANTED AT 14ATM PROXIMAL TO THE FIRST STENT AND OVERLAPPING IT. THE STENTS WERE POST DILATED WITH A 3.0 X 25MM BALLOON AT 28ATM. THERE WAS NO RESIDUAL STENOSIS AND PRE AND POST TIMI FLOW WERE 3. THE DISTAL LEFT ANTERIOR DESCENDING (LAD) WAS 10MM IN LENGTH AND DE NOVO WITH 80% STENOSIS. A 2.5 X 13MM CYPHER RX WAS IMPLANTED AT 15ATM BY DIRECT STENTING AND WITHOUT POST DILATION. THE NEXT DAY, THE PATIENT'S CKMB WAS 14 (ULN 5) AND TROPONIN I WAS 3.407 (ULN 0.05). IT WAS REPORTED THAT THE PATIENT DID NOT HAVE A CARDIAC EVENT AND ECG DID NOT REVEAL ISCHEMIA, THIS HAS SINCE BEEN ADJUDICATED AS A MYOCARDIAL INFARCTION. THE PATIENT WAS DISCHARGED THE DAY AFTER THE INDEX PROCEDURE. THE STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. 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. MYOCARDIAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. 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. 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. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2010-00446, 3003742446-2010-00447 AND 3003742446-2010-0044

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT FOLLOWING THE INDEX PROCEDURE THIS (B)(4) STUDY PATIENT HAD ELEVATED CARDIAC ENZYMES. THIS IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING ANGINA, TARGET VESSEL PERCUTANEOUS CORONARY INTERVENTION AND STENTING (1999), HYPERLIPIDEMIA, HYPERTENSION, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HISTORY OF MYOCARDIAL INFARCTION ((B)(6) 1990), HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), VENTRICULAR TACHYCARDIA WITH ICD PLACEMENT AND SMOKING. AT THE TIME OF THE INDEX PROCEDURE, TWO LESIONS WERE TREATED. THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA, BUT PRE-PROCEDURE CARDIAC ENZYMES WERE WITHIN NORMAL LIMITS. THE MID LEFT ANTERIOR DESCENDING (LAD) LESION WAS 34MM IN LENGTH AND DE NOVO WITH 90% STENOSIS. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER. THE LESION WAS PRE-DILATED WITH A 2.5 X 30MM BALLOON AT 12ATM. A 3.0 X 28MM CYPHER RX WAS IMPLANTED AT 12ATM, AND A 3.0 X 18MM CYPHER RX WAS IMPLANTED AT 14ATM PROXIMAL TO THE FIRST STENT AND OVERLAPPING IT. THE STENTS WERE POST DILATED WITH A 3.0 X 25MM BALLOON AT 28ATM. THERE WAS NO RESIDUAL STENOSIS AND PRE AND POST TIMI FLOW WERE 3. THE DISTAL LEFT ANTERIOR DESCENDING (LAD) WAS 10MM IN LENGTH AND DE NOVO WITH 80% STENOSIS. A 2.5 X 13MM CYPHER RX WAS IMPLANTED AT 15ATM BY DIRECT STENTING AND WITHOUT POST DILATION. THE NEXT DAY, THE PATIENT'S CKMB WAS 14 (ULN 5) AND TROPONIN I WAS 3.407 (ULN 0.05). IT WAS REPORTED THAT THE PATIENT DID NOT HAVE A CARDIAC EVENT AND ECG DID NOT REVEAL ISCHEMIA. THE PATIENT WAS DISCHARGED THE DAY AFTER THE INDEX PROCEDURE. THE 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 15200277 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. CARDIAC ENZYMES ELEVATION IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. 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. 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.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(4) STUDY, A PATIENT EXPERIENCED ELEVATED CARDIAC ENZYMES FOLLOWING THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, TWO LESIONS WERE TREATED. THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA, BUT PRE-PROCEDURE CARDIAC ENZYMES WERE WITHIN NORMAL LIMITS. THE MID LEFT ANTERIOR DESCENDING (LAD) LESION WAS 34MM IN LENGTH AND DE NOVO WITH 90% STENOSIS. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER. THE LESION WAS PRE-DILATED WITH A 2.5 X 30MM BALLOON AT 12ATM. A 3.0 X 28MM CYPHER RX WAS IMPLANTED AT 12ATM, AND A 3.0 X 18MM CYPHER RX WAS IMPLANTED AT 14ATM PROXIMAL TO THE FIRST STENT AND OVERLAPPING IT. THE STENTS WERE POST DILATED WITH A 3.0 X 25MM BALLOON AT 28ATM. THERE WAS NO RESIDUAL STENOSIS AND PRE AND POST TIMI FLOW WERE 3. THE DISTAL LEFT ANTERIOR DESCENDING (LAD) WAS 10MM IN LENGTH AND DE NOVO WITH 80% STENOSIS. A 2.5 X 13MM CYPHER RX WAS IMPLANTED AT 15ATM BY DIRECT STENTING AND WITHOUT POST DILATION. THE NEXT DAY, THE PATIENT'S (B)(6) WAS 14 (ULN 5) AND TROPONIN I WAS 3.407 (ULN 0.05). IT WAS REPORTED THAT THE PATIENT DID NOT HAVE A CARDIAC EVENT AND ECG DID NOT REVEAL ISCHEMIA. THE PATIENT WAS DISCHARGED THE DAY AFTER THE INDEX PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE HEAD END OF STRETCHER WILL NOT LOWER. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    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) 15200277

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other