BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2001615 · Received February 25, 2011

    Report

    Report Number
    3003742446-2011-00108
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 28, 2010
    Report Date
    February 2, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT AFTER THE INDEX PROCEDURE (B)(4) STUDY PATIENT HAD ELEVATED CARDIAC ENZYMES AND APPROXIMATELY ONE YEAR POST PROCEDURE THE PATIENT WAS EXPERIENCING STABLE ANGINA. THIS IS A (B)(6) FEMALE WITH MEDICAL HISTORY INCLUDING ANGINA, HISTORY OF CABG, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, MYOCARDIAL INFARCTION, CONGESTIVE HEART FAILURE, CHRONIC PULMONARY DISEASE, DIABETES MELLITUS AND ALLERGY. FOR THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED WITH UNSTABLE ANGINA. A 70% STENOSIS IN THE PROXIMAL CIRCUMFLEX (CX) WAS PRE-DILATED WITH A 2.5 X 30MM BALLOON AT 8 ATM. A 2.5 X 28MM CYPHER STENT WAS DEPLOYED AT 10ATM SUCCESSFULLY. THE STENT WAS POST-DILATED WITH A 2.5 X 20MM BALLOON AT 18 ATM. THE RESIDUAL STENOSIS WAS 10%. THEN AN 80% STENOSIS IN THE DISTAL CX WAS PRE-DILATED WITH A 2.5 X 30MM BALLOON AT 8 ATM. A 2.5 X 28MM CYPHER STENT WAS DEPLOYED AT 12 ATMS AND A 2.25 X 13MM CYPHER STENT WAS DEPLOYED OVERLAPPING AT 14 ATM. THE STENTS WERE POST-DILATED WITH A 2.75 X 30MM BALLOON AT 20ATM. THEN, A 70% STENOSIS IN THE LEFT MAIN CORONARY ARTERY (LMCA) WAS PRE-DILATED WITH A 2.5 X 30MM BALLOON AT 8ATM. A 2.5 X 28MM CYPHER STENT WAS DEPLOYED AT 14 ATM. THE STENT WAS POST-DILATED WITH A 3.0 X 15MM BALLOON AT 18 ATM. THE INFORMATION RECEIVED INDICATED THAT 6-12 HOURS POST-PROCEDURE THE PATIENT HAD ELEVATED CARDIAC ENZYMES AS FOLLOWS: CK 409 (UL: 234 IU/L) AND CK-MB 49.65 (6.30 NG/ML). THIS WAS NOT TREATED, BUT THE PATIENT WAS MONITORED. APPROXIMATELY A MONTH AND A HALF AFTER THE INDEX PROCEDURE, THE PATIENT HAD A SMALL RETINAL EYE HEMORRHAGE. THE EVENT WAS NOT TREATED AND WAS CONSIDERED OF MODERATE SEVERITY. THE EVENT WAS REPORTED TO BE UNRELATED TO THE INDEX PROCEDURE AND THE CYPHER STENTS, BUT PROBABLY RELATED TO THE STUDY DRUG. THE RETINAL HEMORRHAGE WAS CAPTURED AS A NON-COMPLAINT FOR THE STUDY STENTS. DURING THE 12-MONTH FOLLOW UP, THE PATIENT HAD STABLE ANGINA. THE CLINICAL CIRCUMSTANCES OF THE ANGINA WERE UNKNOWN. THE PATIENT TOOK NITROGLYCERIN, WHICH RELIEVED THE PAIN. IT IS UNKNOWN IF FURTHER TREATMENT WAS DONE FOR THE ANGINA. THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. 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 15048924 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ELEVATED CARDIAC ENZYMES ARE KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND ARE 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. 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 EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. ANGINA IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENT IMPLANTATION AND IS LISTED IN THE IFU AS SUCH. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE ANGINA AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT AND VESSEL FACTORS MAY HAVE CONTRIBUTED TO THE REPORT OF ANGINA. 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 IS ONE OF FOUR PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 3003742446-2011-00107, 3003742446-2011-00108, 3003742446-2011-00109 AND 3003742446-2011-00110.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. CONCOMITANT MEDICAL PRODUCTS: ASPIRIN 325MG ((B)(6) 2009 THROUGH (B)(6) 2011), ATENOLOL 100MG, LIPITOR, 80MG, LIPITOR 40MG, LASIX 80MG, ZANTAC 150MG, ZETIA 10MG AND TRIGLIDE 160MG. THIS IS ONE OF FOUR PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURER REPORT NUMBERS 3003742446-2011-00107, 3003742446-2011-00108, 3003742446-2011-00109 AND 3003742446-2011-00110.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT 6-12 HOURS POST-PROCEDURE THE PATIENT HAD ELEVATED CARDIAC ENZYMES AS FOLLOWS: CK 409 (UL: 234 IU/L) AND CK-MB 49.65 (6.30 NG/ML). THIS WAS NOT TREATED, BUT THE PATIENT WAS MONITORED. FOR THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED WITH UNSTABLE ANGINA. A 70% STENOSIS IN THE PROXIMAL CIRCUMFLEX (CX) WAS PRE-DILATED WITH A 2.5 X 30MM BALLOON AT 8 ATM. A 2.5 X 28MM CYPHER STENT WAS DEPLOYED AT 10ATM SUCCESSFULLY. THE STENT WAS POST-DILATED WITH A 2.5 X 20MM BALLOON AT 18 ATM. THE RESIDUAL STENOSIS WAS 10%. THEN AN 80% STENOSIS IN THE DISTAL CX WAS PRE-DILATED WITH A 2.5 X 30MM BALLOON AT 8 ATM. A 2.5 X 28MM CYPHER STENT WAS DEPLOYED AT 12 ATM AND A 2.25 X 13MM CYPHER STENT WAS DEPLOYED OVERLAPPING AT 14 ATM. THE STENTS WERE POST-DILATED WITH A 2.75 X 30MM BALLOON AT 20ATM. THEN, A 70% STENOSIS IN THE LEFT MAIN CORONARY ARTERY (LMCA) WAS PRE-DILATED WITH A 2.5 X 30MM BALLOON AT 8ATM. A 2.5 X 28MM CYPHER STENT WAS DEPLOYED AT 14 ATM. THE STENT WAS POST-DILATED WITH A 3.0 X 15MM BALLOON AT 18 ATM.

    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 51 YR Life Threatening ASPIRIN 80MG