BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2914077 · Received January 14, 2013

    Report

    Report Number
    3003742446-2013-00020
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    October 3, 2012
    Report Date
    December 19, 2012
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDENDUM AND CORRECTION: ADDITIONAL INFORMATION FROM THE SITE INDICATED THAT THE LESION IN THE SVG TO DISTAL TO OM2 WAS NOT WITHIN 5MM OF THE DCX STUDY STENT. FROM THE CATH REPORT THE PHYSICIAN DICTATES THAT THE ONLY DISEASE IS IN A HIGH OM1 (70%) BUT NO FURTHER DISEASE IN CX SYSTEM; AND LOT OF PLAQUE IN THE PDA. PHYSICIAN DID NOT MENTION ANY OTHER CX DISEASE IN THE OVERALL IMPRESSION EITHER. THE OP REPORT FOR THE CABG DID NOT REFERENCE ANYTHING ABOUT THE STENT IN THE CX. BASED ON THE NEW INFORMATION, PREVIOUSLY REPORTED CODE FOR REOCCLUSION HAS BEEN REMOVED FROM THE DCX STUDY STENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS INCLUDED ACE INHIBITORS, ASPIRIN, BIVALIRUDIN, PLAVIX, COZAAR, HEPARIN, HMG COA REDUCTASE INHIBITORS, HUMULIN R, ISOSORBIDE MONONITRATE, LOVASTATIN, METFORMIN, METOPROLOL, AND NIACIN. THE REPORT RECEIVED FROM THE CYPRESS STUDY INDICATED THAT A PATIENT EXPERIENCED STABLE ANGINA AND UNDERWENT CABG APPROXIMATELY 30 MONTHS POST INDEX PROCEDURE. THIS IS A (B)(6) MALE PATIENT WITH A MEDICAL HISTORY OF ANGINA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, DIABETES MELLITUS, GOUT, NEUROPATHY, HEMICOLECTOMY, ADENOCARCINOMA, AND COLON CANCER. 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 DISTAL CIRCUMFLEX DESCRIBED AS 12MM IN LENGTH, CLASS B1, MILDLY CALCIFIED AND TORTUOUS, AND DE NOVO WITH 90% STENOSIS. THE REFERENCE VESSEL WAS 2.25MM IN DIAMETER. AS PLANNED, THE LESION WAS PRE-DILATED WITH A 2X12MM VOYAGER BALLOON AT 15ATMS AND A 2.25X13MM CYPHER RX WAS IMPLANTED AT 16ATMS. THE SECOND LESION WAS IN THE RPDA DESCRIBED AS 19MM IN LENGTH, CLASS B1, MILDLY CALCIFIED AND TORTUOUS, AND DE NOVO WITH 90% STENOSIS. A 2.75X13MM CYPHER RX WAS IMPLANTED AT 16ATMS AND A 3X13MM CYPHER RX WAS DEPLOYED OVERLAPPING PROXIMAL FROM THE INITIAL STENT TO FULLY COVER THE LESION. CONSEQUENTLY A THIRD 3X8MM CYPHER RX WAS IMPLANTED OVERLAPPING PROXIMAL FROM THE INITIAL STENT TO FULLY COVER THE LESION. AS PER CATH, THERE WAS A GAP BETWEEN MID AND OSTIAL STENTS THAT WAS WHY THE THIRD STENT WAS PLACED. NO COMPLICATIONS REPORTED TO THE STUDY STENTS AND THE PATIENT WAS DISCHARGED A DAY LATER. APPROXIMATELY 30 MONTHS LATER, THE PATIENT HAD A STABLE ANGINA AND UNDERWENT CABG THAT WAS REPORTED AT 33 MONTH VISIT. THE EVENT RESOLVED WITHOUT SEQUELAE. A CABG WAS PERFORMED ON (B)(6) 2012 WITH A LIMA TO THE LAD, SVG TO DISTAL TO OM2, AND SVG DISTAL TO MID PDA (THIS WAS ALSO ENDARTERECTOMIZED). OF NOTE, THE CATH REPORT STATED THE STENTS WERE WIDELY PATENT. IT WAS NOTED IN THE OP REPORT THAT ENDARTERECTOMY WAS DONE TO GET A GOOD LUMEN BECAUSE THE STENTS IN THE PDA HAD A LOT OF PLAQUE IN THEM. THE EVENT WAS NOT RELATED TO THE STUDY STENTS, DRUG, OR PROCEDURE. THE STUDY STENTS REMAIN IMPLANTED IN THE PATIENT 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 15121668 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. FAMILY HISTORY OF CAD, HYPERTENSION AND DIABETES. THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2013-00020, 3003742446-2013-00021, 3003742446-2013-00022, AND 3003742446-2013-00023.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4)STUDY INDICATED THAT A PATIENT EXPERIENCED STABLE ANGINA AND UNDERWENT CABG APPROXIMATELY 30 MONTHS POST INDEX PROCEDURE. AT THE TIME OF INDEX PROCEDURE, THE ANGIOGRAPHY REVEALED TWO VESSELS DISEASED. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA PECTORIS. THE FIRST LESION WAS IN THE DCX DESCRIBED AS 12MM IN LENGTH, CLASS B1, MILDLY CALCIFIED AND TORTUOUS, AND DE NOVO WITH 90% STENOSIS. THE REFERENCE VESSEL WAS 2.25MM IN DIAMETER. AS PLANNED, THE LESION WAS PRE-DILATED WITH A 2X12MM VOYAGER BALLOON AT 15ATMS AND A 2.25X13MM CYPHER RX WAS IMPLANTED AT 16ATMS. THE SECOND LESION WAS IN THE RPDA DESCRIBED AS 19MM IN LENGTH, CLASS B1, MILDLY CALCIFIED AND TORTUOUS, AND DE NOVO WITH 90% STENOSIS. A 2.75X13MM CYPHER RX WAS IMPLANTED AT 16ATMS AND A 3X13MM CYPHER RX WAS DEPLOYED OVERLAPPING PROXIMAL FROM THE INITIAL STENT TO FULLY COVER THE LESION. CONSEQUENTLY A THIRD 3X8MM CYPHER RX WAS IMPLANTED OVERLAPPING PROXIMAL FROM THE INITIAL STENT TO FULLY COVER THE LESION. AS PRE CATH, THERE WAS A GAP BETWEEN MID AND OSTIAL STENTS THAT WAS WHY THE THIRD STENT WAS PLACED. NO COMPLICATIONS REPORTED TO THE STUDY STENTS AND THE PATIENT WAS DISCHARGED A DAY LATER. APPROXIMATELY 30 MONTHS LATER, THE PATIENT HAD A STABLE ANGINA AND UNDERWENT CABG THAT WAS BEING REPORTED AT 33 MONTH VISIT. THE EVENT RESOLVED WITHOUT SEQUELAE. A CABG WAS PERFORMED ON (B)(6) 2012 WITH A LIMA TO THE LAD, SVG TO DISTAL TO OM2, AND SVG DISTAL TO MID PDA (THIS WAS ALSO ENDARTERECTOMIZED). IT WAS NOTED IN THE OP REPORT IT WAS DONE TO GET A GOOD LUMEN BECAUSE THE STENTS IN THE PDA HAD A LOT OF PLAQUE IN IT. HOWEVER, CATH REPORT FOR (B)(6) 2012 REPORTED STENTS WERE WIDELY PATENT, BUT OP REPORT SAID HAD A LOT OF PLAQUE. THE EVENT WAS NOT RELATED TO THE STUDY STENTS, DRUG, OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20642 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15121668

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R