BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2232485 · Received September 2, 2011

    Report

    Report Number
    3003742446-2011-00401
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    April 8, 2010
    Report Date
    August 10, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDENDUM: CEC ADJUDICATION MINUTES RECEIVED INDICATED THAT THE PATIENT EXPERIENCED PERIPROCEDURAL MYOCARDIAL INFARCTION POST INDEX PROCEDURE. IT WAS REPORTED THAT THE TROPONIN I WAS 0.36 (0.08 UNL) POST INDEX PROCEDURE. AS PER THE ADJUDICATION REPORT, THE ECG CORE LAB REPORTED UNINTERPRETABLE MI DUE TO PACED RHYTHM. THE ELEVATED TROPONIN WAS LATER DIAGNOSED AS A PERIPROCEDURAL MI BASED ON THE RECEIVED ADJUDICATION MINUTES. COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT SUFFERED A PERI-PROCEDURE MI DURING THE STUDY INDEX PROCEDURE AND SIDE BRANCH RESTENOSIS APPROXIMATELY 15 MONTHS POST INDEX. THE PATIENT WAS A (B)(6) MALE WITH A HISTORY OF ANGINA, HYPERTENSION, ATRIAL FIBRILLATION, SMOKING, BLADDER CANCER (1985), HISTORY OF DYE ALLERGY (REQUIRING PREMEDICATION) AND FAMILY HISTORY OF CORONARY ARTERY DISEASE. INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA PECTORIS. THE TARGET LESION WAS THE MID LAD WITH IN 5 MM OF A PREVIOUSLY PLACED CYPHER STENT. THE VESSEL DIAMETER WAS 3MM AND THE LESION LENGTH WAS 30MM. TARGET LESION CLASSIFICATION WAS A. THE LESION WAS DE NOVO AND 70% STENOSED. FIRST A (B)(4) WAS DIRECTLY STENTED AT 18ATM. AND THEN, A (B)(4) WAS THEN DEPLOYED AT 18ATM, OVERLAPPING AND PROXIMAL TO THE PREVIOUS STENT. POST-PROCEDURE STENOSIS WAS 0%. PRE-PROCEDURE THE CK WAS 52, THE CKMB WAS 1.3 AND THE TROPONIN WAS NOT COLLECTED. POST PROCEDURE THE CK WAS 53; THE CKMB AND THE TROPONIN WERE NOT COLLECTED. LATER THE CK WAS 55, THE CKMB WAS 2.2 AND THE TROPONIN WAS 0.05. THE LAST SET OF ENZYMES DRAWN REVEALED A CK OF 67, A CKMB OF 4.1 AND THE TROPONIN WAS 0.36. THIS ENZYME ELEVATION EVENT HAS BEEN DEEMED BY THE CEC COMMITTEE TO BE AN ARC (PERI-PROCEDURAL PCI) THUS THE FILE WAS CODED FOR MI. THE ECG LAB REPORTED UNINTERPRETABLE MI DUE TO PACED RHYTHM. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON DUAL ANTI-PLATELET THERAPY. IT WAS REPORTED THAT THE PATIENT HAD ANGINA AND A BALLOON ANGIOPLASTY OF THE DESCENDING CORONARY ARTERY IN (B)(6) 2011. FURTHER INFORMATION RECEIVED: THE PATIENT REPORTED THE PTCA, HOWEVER, WHEN FILMS WERE RECEIVED. A CATHETERIZATION WAS CONDUCTED ON (B)(6) 2011 AND NO PTCA WAS PERFORMED. THE DIAGONAL ONLY HAD 40% STENOSIS. THIS WAS CAPTURED AS CORONARY REOCCLUSION. THE STUDY 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. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS 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. 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. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, SPECIFICALLY THE RISK FACTORS FOR ATHEROSCLEROTIC DISEASE; I.E. HYPERTENSION AND SMOKING. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00401 AND 3003742446-2011-00402.

    Additional Manufacturer Narrative · 1

    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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 3003742446-2011-00402. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THE CHANGE OF INFORMATION. WITH THE NEW INFORMATION, THIS EVENT NO LONGER MEETS THE REQUIREMENTS FOR REPORTABILITY TO THE FDA.

    Description of Event or Problem · 1

    INFORMATION RECEIVED (B)(6) 2011: THE PATIENT REPORTED THE PTCA. HOWEVER, WHEN FILMS WERE RECEIVED A CATH WAS CONDUCTED ON (B)(6) 2011 AND NO PTCA WAS PERFORMED. THE DIAGONAL ONLY HAD 40% STENOSIS.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED WAS FROM THE (B)(4) STUDY. THE PATIENT WAS A (B)(6) MALE WITH A HISTORY OF ANGINA, HYPERTENSION, ATRIAL FIBRILLATION, SMOKING, BLADDER CANCER (1985), HISTORY OF DYE ALLERGY (REQUIRING PREMEDICATION) AND FAMILY HISTORY OF CORONARY ARTERY DISEASE. INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA PECTORIS. THE TARGET LESION WAS THE MID LAD. THE VESSEL DIAMETER WAS 3MM AND THE LESION LENGTH WAS 30MM. TARGET LESION CLASSIFICATION WAS A. THE LESION WAS DE NOVO AND 70% STENOSED. A CXS13300 WAS DIRECT STENTED AT 18ATM. A CXS23350 WAS THEN DEPLOYED AT 18ATM, OVERLAPPING AND PROXIMAL TO THE PREVIOUS STENT. POST-PROCEDURE STENOSIS WAS 0%. THE PATIENT HAD ANGINA AND A BALLOON ANGIOPLASTY OF THE ASCENDING CORONARY ARTERY ON (B)(6) 2011.

    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 70 YR Life Threatening| R ASPIRIN AND CLOPIDOGREL