BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2980141 · Received February 27, 2013

    Report

    Report Number
    3003742446-2013-00045
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    March 29, 2012
    Report Date
    February 5, 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

    ADDITIONAL INFORMATION IN THE REVISED CRF INDICATED THAT A PATIENT UNDERWENT CABG OF THE 2ND DIAGONAL, MID RCA, PROXIMAL CX, AND RPDA APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE. THE EVENT RESOLVED WITHOUT SEQUELAE. THE EVENT WAS NOT RELATED TO THE STUDY STENTS, DRUG, OR PROCEDURE IN AN INVESTIGATOR'S OPINION. THE STUDY STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. CONCOMITANT MEDICATIONS INCLUDED: CARDIZEM 120MG SINCE 01/012010, LIPITOR 80MG SINCE 01/012009, ASPIRIN 325MG SINCE 01/01/2010, LOPRESSOR 50MG BID SINCE 01/01/2011, PREVACID 30MG BID SINCE 01/01/2011, ATIVAN 1MG TID SINCE 01/01/2011, MORPHINE 30MG TID SINCE 01/01/2011, PROAIR 90MG BID SINCE 01/01/2011. THIS IS AN INITIAL/FINAL MDR. AS REPORTED VIA THE (B)(4) STUDY, A PATIENT EXPERIENCED AN IN-STENT RESTENOSIS APPROXIMATELY EIGHTEEN MONTHS AND 24 MONTHS AFTER THE INDEX PROCEDURE. THIS IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, CVA/STROKE (1996), TIA, COPD, SYSTEMIC LUPUS ERYTHEMATOSUS, RADIATION CYSTITIS WITH OCCASIONAL HEMATURIA, BRONCHIECTASIS, OSTEOPENIA, PROSTATE CANCER (07/2004), AORTIC STENOSIS, AND SMOKER. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 90% STENOSIS IN THE PROXIMAL RCA AND 70% STENOSIS IN THE MID RCA. THE MID RCA LESION WAS 8MM IN LENGTH, DE NOVO, AND MILDLY CALCIFIED. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER AND MILDLY TORTUOUS. THE LESION WAS PRE-DILATED WITH A 3.0 X 12MM BALLOON AT 16ATM. AN INITIAL 3.0 X 13MM CYPHER STENT FAILED TO CROSS THE MID RCA LESION AND WAS WITHDRAWN. A 3.0 X 13MM CYPHER WAS IMPLANTED AT 20ATM AND WAS POST-DILATED PER STANDARD PROCEDURE WITH A 3.5 X 12MM BALLOON AT 20ATM. THE PROXIMAL RCA LESION WAS 8MM IN LENGTH, MILDLY CALCIFIED AND DE NOVO. THE REFERENCE VESSEL WAS 3.75MM IN DIAMETER. THE LESION WAS PRE-DILATED WITH A 3.0 X 12MM BALLOON AT 16ATM. A 3.5 X 13MM CYPHER WAS IMPLANTED AT 16ATM AND WAS POST-DILATED PER STANDARD PROCEDURE WITH A 4.0 X 10MM BALLOON A 24ATM. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. APPROXIMATELY 18 MONTHS AFTER THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 85% RESTENOSIS TO THE OSTIAL RCA LESION THAT WAS TREATED WITH A 4.0 X 16MM NON-CORDIS STENT. THE INDICATION FOR THE REVASCULARIZATION PROCEDURE WAS ACS. THE OUTCOME WAS SUCCESSFUL WITH NO COMPLICATIONS OR RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. AT THE 24 MONTH FOLLOW UP THE PATIENT REPORTED ANGINA. NO ANGIOGRAPHY OR FURTHER TESTING WAS PERFORMED FOR THIS EVENT. ADDITIONAL INFORMATION IN THE REVISED CRF INDICATED THAT A PATIENT UNDERWENT CABG OF THE 2ND DIAGONAL, MID RCA, PROXIMAL CX, AND RPDA APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE. THE EVENT RESOLVED WITHOUT SEQUELAE. THE EVENT WAS NOT RELATED TO THE STUDY STENTS, DRUG, OR PROCEDURE IN AN INVESTIGATOR'S OPINION. 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 15094585 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. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, SPECIFICALLY THE RISK FACTORS FOR ATHEROSCLEROTIC DISEASE; I.E. VASCULAR DISEASE AND SMOKING. CHEST PAIN/ANGINA IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE CYPHER IFU AS SUCH. 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. THE NATURAL PROGRESSION OF CORONARY DISEASE AS WELL AS TARGET LESION ISSUES MAY CONTRIBUTE TO THE EXPERIENCE OF CHEST PAIN / ANGINA. 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. REVIEW OF THE INFORMATION SUGGESTS THAT LESION, VESSEL AND PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2013-00045 AND 3003742446-2011-00475.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(4) STUDY, A PATIENT EXPERIENCED AN IN-STENT RESTENOSIS APPROXIMATELY EIGHTEEN MONTHS AND 24 MONTHS AFTER THE INDEX PROCEDURE. THIS IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, CVA/STROKE (1996), TIA, COPD, SYSTEMIC LUPUS ERYTHEMATOSUS, RADIATION CYSTITIS WITH OCCASIONAL HEMATURIA, BRONCHIECTASIS, OSTEOPENIA, PROSTATE CANCER (07/2004), AORTIC STENOSIS, AND SMOKER. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 90% STENOSIS IN THE PROXIMAL RCA AND 70% STENOSIS IN THE MID RCA. THE MID RCA LESION WAS 8MM IN LENGTH, DE NOVO, AND MILDLY CALCIFIED. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER AND MILDLY TORTUOUS. THE LESION WAS PRE-DILATED WITH A 3.0 X 12MM BALLOON AT 16ATM. AN INITIAL 3.0 X 13MM CYPHER STENT FAILED TO CROSS THE MID RCA LESION AND WAS WITHDRAWN. A 3.0 X 13MM CYPHER WAS IMPLANTED AT 20ATM AND WAS POST-DILATED PER STANDARD PROCEDURE WITH A 3.5 X 12MM BALLOON AT 20ATM. THE PROXIMAL RCA LESION WAS 8MM IN LENGTH, MILDLY CALCIFIED AND DE NOVO. THE REFERENCE VESSEL WAS 3.75MM IN DIAMETER. THE LESION WAS PRE-DILATED WITH A 3.0 X 12MM BALLOON AT 16ATM. A 3.5 X 13MM CYPHER WAS IMPLANTED AT 16ATM AND WAS POST-DILATED PER STANDARD PROCEDURE WITH A 4.0 X 10MM BALLOON A 24ATM. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. APPROXIMATELY 18 MONTHS AFTER THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 85% RESTENOSIS TO THE OSTIAL RCA LESION THAT WAS TREATED WITH A 4.0 X 16MM NON-CORDIS STENT. THE INDICATION FOR THE REVASCULARIZATION PROCEDURE WAS ACS. THE OUTCOME WAS SUCCESSFUL WITH NO COMPLICATIONS OR RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. AT THE 24 MONTH FOLLOW UP THE PATIENT REPORTED ANGINA. NO ANGIOGRAPHY OR FURTHER TESTING WAS PERFORMED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84870 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15094585

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention