BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 3181333 · Received June 21, 2013

    Report

    Report Number
    3003742446-2013-00076
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 6, 2011
    Report Date
    May 30, 2013
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS INCLUDED ASPIRIN, BIVALIRUDIN, LISINOPRIL, METOPROLOL, NAPROXEN, PEPCID, PRASUGREL, AND SIMVASTATIN. THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT EXPERIENCED CORONARY ARTERY RESTENOSIS APPROXIMATELY 7 MONTHS POST INDEX PROCEDURE. THE PATIENT HAD A PREVIOUS PCI ON (B)(6) 2010 PRIOR TO THE INDEX PROCEDURE. NO INFORMATION IS AVAILABLE. THE PATIENT¿S MEDICAL HISTORY IS SIGNIFICANT FOR - PATIENT MEDICAL HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, ANGINA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, ALLERGY (MORPHINE) AND SMOKER. AT THE TIME OF INDEX PROCEDURE, THE ANGIOGRAPHY REVEALED TWO VESSELS DISEASE. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA PECTORIS. THE FIRST LESION WAS IN THE MLAD DESCRIBED AS 10MM IN LENGTH, CLASS B1, AND DE NOVO WITH 70% STENOSIS. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER. A 3.0X18MM CYPHER RX (# 15189347) WAS IMPLANTED AT 18ATMS. THE SECOND LESION WAS IN THE 1ST OM DESCRIBED AS 20MM IN LENGTH, CLASS B2, AND DE NOVO WITH 80% STENOSIS. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. A 2.5X28MM CYPHER RX (# 15229523) WAS IMPLANTED AT 9ATMS. THE STENT WAS POST-DILATED USING A 2.5X28MM BALLOON AT 6ATMS IN ORDER TO ACHIEVE OPTIMAL EXPANSION. THERE WERE NO PROCEDURAL COMPLICATIONS REPORTED AND THE PATIENT WAS DISCHARGED A DAY LATER. 7 MONTHS LATER, THE PATIENT HAD A REVASCULARIZATION OF THE MID-PROXIMAL LAD AND CIRCUMFLEX OBTUSE MARGINAL. THE LESION IN THE LAD WAS NOT WITHIN 5MM OF LAD STUDY STENT HOWEVER, NEW STENT WAS PLACED IN THE MLAD. THE OTHER STENT IN THE (B)(6) 2011 INTERVENTION WAS ACTUALLY IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY AND NOT IN THE OM1. THE LAD STUDY STENT WAS NOT RESTENOSED. IN THE (B)(6) 2011 PTCA REPORT IT WAS DICTATED THAT THE CIRCUMFLEX OBTUSE MARGINAL BRANCH HAS AN IRREGULAR ELONGATED AREA OF 70% STENOSIS. THE PHYSICIAN MAY ACTUALLY BE TALKING ABOUT THE LEFT CIRCUMFLEX, WHICH HE STENTED DURING THIS PROCEDURE. THE CATH LAB REPORT CONFIRMS THAT THE LEFT CIRCUMFLEX WAS STENTED. IT IS UNCLEAR WHETHER OR NOT THE OM1 STUDY STENT WAS FOUND TO BE RESTENOSED IN THIS PROCEDURE. TWO STENTS (SCHIMED) WERE PLACED. IT IS UNKNOWN IF THE NEW LESIONS WERE WITHIN 5MM OF BOTH STUDY STENTS. (B)(4): 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 15189347 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4): 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 15229523 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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 3003742446-2013-00076 AND 3003742446-2013-00077.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT EXPERIENCED CORONARY ARTERY RESTENOSIS APPROXIMATELY 7 MONTHS POST INDEX PROCEDURE. THE PATIENT HAD A PREVIOUS PCI ON (B)(6) 2010 PRIOR TO THE INDEX PROCEDURE. NO INFORMATION IS AVAILABLE. AT THE TIME OF INDEX PROCEDURE, THE ANGIOGRAPHY REVEALED TWO VESSELS DISEASE. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA PECTORIS. THE FIRST LESION WAS IN THE MLAD DESCRIBED AS 10MM IN LENGTH, CLASS B1, AND DE NOVO WITH 70% STENOSIS. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER. A 3.0X18MM CYPHER RX (# 15189347) WAS IMPLANTED AT 18ATMS. THE SECOND LESION WAS IN THE 1ST OM DESCRIBED AS 20MM IN LENGTH, CLASS B2, AND DE NOVO WITH 80% STENOSIS. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. A 2.5X28MM CYPHER RX (# 15229523) WAS IMPLANTED AT 9ATMS. THE STENT WAS POST-DILATED USING A 2.5X28MM BALLOON AT 6ATMS IN ORDER TO ACHIEVE OPTIMAL EXPANSION. THERE WERE NO PROCEDURAL COMPLICATIONS REPORTED AND THE PATIENT WAS DISCHARGED A DAY LATER. 7 MONTHS LATER, THE PATIENT HAD A REVASCULARIZATION OF THE MID-PROXIMAL LAD AND CIRCUMFLEX OBTUSE MARGINAL. THE LESION IN THE LAD WAS NOT WITHIN 5MM OF LAD STUDY STENT HOWEVER NEW STENT WAS PLACED IN THE MLAD. THE OTHER STENT IN THE (B)(6) 2011 INTERVENTION WAS ACTUALLY IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY AND NOT IN THE OM1. THE LAD STUDY STENT WAS NOT RESTENOSED. IN THE (B)(6) 2011 PTCA REPORT, IT WAS DICTATED THAT THE CIRCUMFLEX OBTUSE MARGINAL BRANCH HAS AN IRREGULAR ELONGATED AREA OF 70% STENOSIS. THE PHYSICIAN MAY ACTUALLY BE TALKING ABOUT THE LEFT CIRCUMFLEX, WHICH HE STENTED DURING THIS PROCEDURE. THE CATH LAB REPORT CONFIRMS THAT THE LEFT CIRCUMFLEX WAS STENTED. IT IS UNCLEAR WHETHER OR NOT THE OM1 STUDY STENT WAS FOUND TO BE RESTENOSED IN THIS PROCEDURE. TWO STENTS (SCHIMED) WERE PLACED. IT IS UNKNOWN IF THE NEW LESIONS WERE WITHIN 5MM OF BOTH STUDY STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282030 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15189347

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention