BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2994184 · Received March 8, 2013

    Report

    Report Number
    3003742446-2013-00049
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    January 20, 2012
    Report Date
    February 15, 2013
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS 0% RESIDUAL AND THERE WAS NO POST DILATION. THE DISTAL LEFT ARTERY DESCENDING (LAD) WAS 10MM IN LENGTH, PROXIMAL, B1, DE NOVO AND WITH 80% STENOSIS. THE REFERENCE VESSEL WAS 3.0 IN DIAMETER. A 3.0 X 18MM CYPHER RX (LOT # 15125453) WAS IMPLANTED BY DIRECT STENTING AT 15ATM. THE STENT WAS POST-DILATED WITH A 3.0 X 15MM BALLOON AT 15ATM WITH 0% RESIDUAL. CK-MB PEAKED AT 15.2 (5.0) AT 6 TO 12 HOURS POST PROCEDURE. CK-MB PEAKED AT 13.7 (5.0) AND TROPONIN T PEAKED AT 0.10 (0.03) AT 16 TO 24 HOURS POST PROCEDURE. THERE WERE NO COMPLICATION REPORTED AND THE PATIENT WAS DISCHARGED THE NEXT DAY. TWENTY MONTHS AFTER THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED CORONARY ARTERY STENOSIS RESULTING IN A CORONARY ARTERY BYPASS SURGERY (CABG) TO THE LAD, RAMUS, AND OBTUSE MARGINAL. ANGIOGRAPHY DONE AT THIS TIME REVEALED THE STUDY STENTS TO BE WIDELY PATENT; HOWEVER, WAS WITHIN 5 MM OF THE STUDY STENTS. PER THE INVESTIGATOR, THE EVENT RESOLVED AND IT WAS REPORTED TO NOT BEING RELATED TO THE INDEX PROCEDURE OR THE CYPHER STUDY STENTS. ADDITIONAL INFORMATION RECEIVED FROM THE SITE. AS PER CATH REPORT FROM INDEX PROCEDURE, THERE WERE FOUR CYPHER STENTS PLACED EACH IN THE DISTAL CX, PROXIMAL CX, DISTAL LAD, AND PROXIMAL LAD AND ONLY BALLOON ANGIOPLASTY IN THE 2ND OBTUSE MARGINAL. PREVIOUSLY THE CRF WAS UPLOADED IN ERROR AT THE TIME OF INITIAL REPORT INDICATING THAT THERE WERE FOUR CYPHER STENTS PLACED EACH IN THE DISTAL CX, PROXIMAL CX, DISTAL LAD, AND 2ND OBTUSE MARGINAL AND ONLY BALLOON ANGIOPLASTY IN THE PROXIMAL LAD. FINAL RESOLUTION HAS BEEN RECEIVED REGARDING WHICH VESSEL HAD A CYPHER STENT PLACED AND WHICH VESSEL HAD ONLY BALLOON ANGIOPLASTY DONE. THERE WAS SOME DISCREPANCY IN THE INFORMATION. FINALLY IT¿S CONFIRMED THAT THE PROXIMAL LAD WAS STENTED WITH A CYPHER STENT AND 2ND OBTUSE MARGINAL WAS TREATED WITH A BALLOON ANGIOPLASTY ONLY. AS PREVIOUSLY REPORTED, THE PATIENT HAD A CABG ON (B)(6) 2012 THAT INVOLVED LAD, RAMUS, AND OBTUSE MARGINAL. THE EVENT OF REOCCLUSION CANNOT BE RULED OUT FROM BOTH STUDY STENTS IN THE LAD. THE DISTAL LAD STUDY STENT WAS PREVIOUSLY REPORTED AT THE TIME OF INITIAL REPORT. CONCOMITANT MEDICATIONS: METOPROLOL 25MG QD, ASPIRIN 325 QD, AMITRIPTYLINE 30MG TID, NEURONTIN 900MG TID, CRESTOR 21MG QD. UPDATED COMPLAINT CONCLUSION: AS REPORTED BY THE (B)(4) STUDY, A PATIENT EXPERIENCED MULTI-VESSEL CORONARY ARTERY STENOSIS TWENTY MONTHS AFTER THE INDEX PROCEDURE. THIS IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING ANGINA, HYPERLIPIDEMIA, HYPERTENSION, SMOKING (WITHIN 30 DAYS) AND FAMILY HISTORY OF CORONARY ARTERY DISEASE, AND ALLERGIES TO HYDROCHLOROTHIAZIDE, LIPITOR, AND STATINS. THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE STABLE ANGINA PECTORIS AND NON-ST SEGMENT ELEVATION WITH ACUTE CORONARY SYNDROME PRESENT. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED STENOSIS IN FOUR VESSELS. THE DISTAL CIRCUMFLEX LESION WAS 15MM IN LENGTH, DE NOVO, B2, AND WITH 90% STENOSIS. THE REFERENCE VESSEL WAS 2.5 IN DIAMETER. THE LESION WAS PRE-DILATED WITH A 2.5 X 15MM BALLOON AT 18ATM AND A 2.5 X 23MM CYPHER RX (LOT # 15112842) WAS IMPLANTED AT 14ATM. THE STENT WAS POST DILATED WITH A 2.5 X 20MM BALLOON AT 18ATM AND WITH 0% RESIDUAL. THE PROXIMAL CIRCUMFLEX LESION WAS 10MM IN LENGTH, DE NOVO, B1 AND WITH 80% STENOSIS. THE REFERENCE VESSEL WAS 3.0 IN DIAMETER. THE LESION WAS PRE-DILATED WITH A 2.5 X 15MM BALLOON AT 16ATM AND A 3.0 X 18MM CYPHER RX (LOT # 15125453) CYPHER RX WAS IMPLANTED AT 16ATM. THE STENT WAS POST DILATED WITH A 3.0 X 15MM BALLOON AT 18ATM AND WITH 0% RESIDUAL. THE PROXIMAL LEFT ARTERY DESCENDING (LAD) WAS 2MM IN LENGTH, DE NOVO AND OSTIAL. THE REFERENCE VESSEL WAS 2.5 IN DIAMETER AND LESION INCLUDED SIDE BRANCH MORE THAN 2.5MM. THE LESION WAS TREATED WITH A BALLOON ANGIOPLASTY DUE TO A SIDE BRANCH OCCLUSION. NO CORDIS PRODUCTS HAD BEEN USED IN THE LAD AT THE TIME OF THE SIDE BRANCH OCCLUSION. STENT WAS NOT USED AND THERE WAS 30% RESIDUAL STENOSIS. THE SECOND DISTAL OBTUSE MARGINAL WAS 8MM IN LENGTH, B1, DE NOVO, AND WITH 90% STENOSIS. THE REFERENCE VESSEL WAS 2.5 IN DIAMETER. THE LESION WAS PRE-DILATED WITH A 2.0 X 12MM BALLOON AT 10ATM AND A 2.5 X 13MM CYPHER RX (LOT #15127440) WAS IMPLANTED AT 13ATM. THERE WAS 0% RESIDUAL AND THERE WAS NO POST DILATION. THE DISTAL LEFT ARTERY DESCENDING (LAD) WAS 10MM IN LENGTH, PROXIMAL, B1, DE NOVO AND WITH 80% STENOSIS. THE REFERENCE VESSEL WAS 3.0 IN DIAMETER. A 3.0 X 18MM CYPHER RX (LOT # 15125453) WAS IMPLANTED BY DIRECT STENTING AT 15ATM. THE STENT WAS POST-DILATED WITH A 3.0 X 15MM BALLOON AT 15ATM WITH 0% RESIDUAL. CK-MB PEAKED AT 15.2 (5.0) AT 6 TO 12 HOURS POST PROCEDURE. CK-MB PEAKED AT 13.7 (5.0) AND TROPONIN T PEAKED AT 0.10 (0.03) AT 16 TO 24 HOURS POST PROCEDURE. THERE WERE NO COMPLICATION REPORTED AND THE PATIENT WAS DISCHARGED THE NEXT DAY. TWENTY MONTHS AFTER THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED CORONARY ARTERY STENOSIS RESULTING IN A CORONARY ARTERY BYPASS SURGERY (CABG) TO THE LAD, RAMUS, AND OBTUSE MARGINAL. ANGIOGRAPHY DONE AT THIS TIME REVEALED THE STUDY STENTS TO BE WIDELY PATENT; HOWEVER, WAS WITHIN 5 MM OF THE STUDY STENTS. PER THE INVESTIGATOR, THE EVENT RESOLVED AND IT WAS REPORTED TO NOT BEING RELATED TO THE INDEX PROCEDURE OR THE CYPHER STUDY STENTS. ADDITIONAL INFORMATION RECEIVED FROM THE SITE. AS PER CATH REPORT FROM INDEX PROCEDURE, THERE WERE FOUR CYPHER STENTS PLACED EACH IN THE DISTAL CX, PROXIMAL CX, DISTAL LAD, AND PROXIMAL LAD AND ONLY BALLOON ANGIOPLASTY IN THE 2ND OBTUSE MARGINAL. PREVIOUSLY THE CRF WAS UPLOADED IN ERROR AT THE TIME OF INITIAL REPORT INDICATING THAT THERE WERE FOUR CYPHER STENTS PLACED EACH IN THE DISTAL CX, PROXIMAL CX, DISTAL LAD, AND 2ND OBTUSE MARGINAL AND ONLY BALLOON ANGIOPLASTY IN THE PROXIMAL LAD. FINAL RESOLUTION HAS BEEN RECEIVED REGARDING WHICH VESSEL HAD A CYPHER STENT PLACED AND WHICH VESSEL HAD ONLY BALLOON ANGIOPLASTY DONE. THERE WAS SOME DISCREPANCY IN THE INFORMATION. FINALLY, IT'S CONFIRMED THAT THE PROXIMAL LAD WAS STENTED WITH A CYPHER STENT AND 2ND OBTUSE MARGINAL WAS TREATED WITH A BALLOON ANGIOPLASTY ONLY. AS PREVIOUSLY REPORTED, THE PATIENT HAD A CABG ON 01/20/2012 THAT INVOLVED LAD, RAMUS, AND OBTUSE MARGINAL. THE EVENT OF REOCCLUSION CANNOT BE RULED OUT FROM BOTH STUDY STENTS IN THE LAD. THE DISTAL LAD STUDY STENT WAS PREVIOUSLY REPORTED AT THE TIME OF INITIAL REPORT. THE CYPHER 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 15125453 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 3003742446-2013-00049 AND 3003742446-2012-00060.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, A PATIENT EXPERIENCED MULTI-VESSEL CORONARY ARTERY STENOSIS TWENTY MONTHS AFTER THE INDEX PROCEDURE. THIS IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING ANGINA, HYPERLIPIDEMIA, HYPERTENSION, SMOKING (WITHIN 30 DAYS) AND FAMILY HISTORY OF CORONARY ARTERY DISEASE, AND ALLERGIES TO HYDROCHLOROTHIAZIDE, LIPITOR, AND STATINS. THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE STABLE ANGINA PECTORIS AND NON-ST SEGMENT ELEVATION WITH ACUTE CORONARY SYNDROME PRESENT. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED STENOSIS IN FOUR VESSELS. THE DISTAL CIRCUMFLEX LESION WAS 15MM IN LENGTH, DE NOVO, B2, AND WITH 90% STENOSIS. THE REFERENCE VESSEL WAS 2.5 IN DIAMETER. THE LESION WAS PRE-DILATED WITH A 2.5 X 15MM BALLOON AT 18ATM AND A 2.5 X 23MM CYPHER RX (LOT # 15112842) WAS IMPLANTED AT 14ATM. THE STENT WAS POST DILATED WITH A 2.5 X 20MM BALLOON AT 18ATM AND WITH 0% RESIDUAL. THE PROXIMAL CIRCUMFLEX LESION WAS 10MM IN LENGTH, DE NOVO, B1 AND WITH 80% STENOSIS. THE REFERENCE VESSEL WAS 3.0 IN DIAMETER. THE LESION WAS PRE-DILATED WITH A 2.5 X 15MM BALLOON AT 16ATM AND A 3.0 X 18MM CYPHER RX (LOT # 15125453) CYPHER RX WAS IMPLANTED AT 16ATM. THE STENT WAS POST DILATED WITH A 3.0 X 15MM BALLOON AT 18ATM AND WITH 0% RESIDUAL. THE PROXIMAL LEFT ARTERY DESCENDING (LAD) WAS 2MM IN LENGTH, DE NOVO AND OSTIAL. THE REFERENCE VESSEL WAS 2.5 IN DIAMETER AND LESION INCLUDED SIDE BRANCH MORE THAN 2.5MM. THE LESION WAS TREATED WITH A BALLOON ANGIOPLASTY DUE TO A SIDE BRANCH OCCLUSION. NO CORDIS PRODUCTS HAD BEEN USED IN THE LAD AT THE TIME OF THE SIDE BRANCH OCCLUSION. STENT WAS NOT USED AND THERE WAS 30% RESIDUAL STENOSIS. THE SECOND DISTAL OBTUSE MARGINAL WAS 8MM IN LENGTH, B1, DE NOVO, AND WITH 90% STENOSIS. THE REFERENCE VESSEL WAS 2.5 IN DIAMETER. THE LESION WAS PRE-DILATED WITH A 2.0 X 12MM BALLOON AT 10ATM AND A 2.5 X 13MM CYPHER RX (LOT #15127440) WAS IMPLANTED AT 13ATM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98944 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15125453

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention