BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2536364 · Received April 16, 2012

    Report

    Report Number
    3003742446-2012-00077
    Event Type
    Injury
    Date Received
    April 16, 2012
    Date of Event
    March 30, 2011
    Report Date
    March 23, 2012
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS INCLUDED ASPIRIN, CARVEDILOL, IRON, LISINOPRIL, PANTOPRAZOLE, PLAVIX, AND SIMVASTATIN. COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT APPROXIMATELY 6 MONTHS POST IMPLANTATION, THE PATIENT SUFFERED INSTENT RESTENOSIS. AS REPORTED VIA MEDICAL AFFAIRS, A PATIENT REPORTED BREATHING DIFFICULT AND ONE END OF THE STENTS WAS BLOCKED AND GROWING FEELERS APPROXIMATELY SIX MONTHS AFTER THE INITIAL STENTS IMPLANTATION. THIS IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING CAD, ACID REFLUX, ULCERATED ESOPHAGUS, FALL, BACK SURGERY, SMOKING, ALLERGIC TO OCN, SPRING ALLERGIES, HAY FEVER, AND BRUISED EASILY. DURING INITIAL STENTS IMPLANTATION ((B)(6) 2010), THE ANGIOGRAPHY REVEALED 100% STENOSIS IN THE PROXIMAL AND MID LAD. THE INDICATION FOR THE PROCEDURE WAS CHEST PAIN, ACUTE MI, AND HEART FAILURE. THE PROXIMAL LESION WAS DESCRIBED AS 15MM IN LENGTH WITH 100% STENOSIS. PRE PROCEDURE TIMI FLOW WAS NOTED AS 0. THE LESION WAS TREATED WITH A 2.25 X 13MM CYPHER RX AT 11ATM PRESSURE. THE POST PROCEDURE TIMI FLOW WAS 3. THE RESIDUAL PERCENTAGE OF STENOSIS WAS 0%. THE LESION WAS DIAGNOSED AS A HIGH RISK LESION. THE MID LAD LESION WAS DESCRIBED AS 15MM IN LENGTH WITH 100% STENOSIS. PRE PROCEDURE TIMI FLOW WAS 0. THE LESION WAS TREATED WITH A 2.25 X 23MM CYPHER RX STENT AT 11ATM PRESSURE. THE POST PROCEDURE TIMI FLOW WAS 3. THE RESIDUAL PERCENTAGE OF STENOSIS WAS 0%. IT WAS REPORTED THAT THERE WAS SEVERE DIFFUSE DISEASE IN THE MID AND DISTAL LAD. APPROXIMATELY SIX MONTHS AFTER THE STENTS IMPLANTATION, THE PATIENT WAS HOSPITALIZED DUE TO THE SHORTNESS OF BREATH. THE ANGIOGRAPHY REVEALED 30% PROXIMAL LAD INSTENT RESTENOSIS AND 100% MID LAD INSTENT RESTENOSIS. IT WAS REPORTED THAT THE EVENT WAS RESOLVED. 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 15201942 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 IS 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. CAD AND SMOKING. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2012-00077 AND 3003742446-2012-00078.

    Description of Event or Problem · 1

    AS REPORTED VIA MEDICAL AFFAIRS, A PATIENT REPORTED SHORTNESS OF BREATH AND ONE END OF THE STENTS WAS BLOCKED THAT WAS LATER DIAGNOSED AS 30% INSTENT RESTENOSIS OF THE PROXIMAL LAD AND 100% INSTENT RESTENOSIS OF THE MID LAD APPROXIMATELY SIX MONTHS POST INITIAL STENTS IMPLANTATION. DURING INITIAL STENTS IMPLANTATION ((B)(6) 2010), THE ANGIOGRAPHY REVEALED 100% STENOSIS IN THE PROXIMAL AND MID LAD. THE INDICATION FOR THE PROCEDURE WAS CHEST PAIN, ACUTE MI, AND HEART FAILURE. THE PROXIMAL LESION WAS DESCRIBED AS 15MM IN LENGTH WITH 100% STENOSIS. PRE PROCEDURE TIMI FLOW WAS NOTED AS 0. THE LESION WAS TREATED WITH A 2.25 X 13MM CYPHER RX AT 11ATM PRESSURE. THE POST PROCEDURE TIMI FLOW WAS 3. THE RESIDUAL PERCENTAGE OF STENOSIS WAS 0%. THE LESION WAS DIAGNOSED AS A HIGH RISK LESION. THE MID LAD LESION WAS DESCRIBED AS 15MM IN LENGTH WITH 100% STENOSIS. PRE PROCEDURE TIMI FLOW WAS 0. THE LESION WAS TREATED WITH A 2.25 X 23MM CYPHER RX STENT AT 11ATM PRESSURE. THE POST PROCEDURE TIMI FLOW WAS 3. THE RESIDUAL PERCENTAGE OF STENOSIS WAS 0%. IT WAS REPORTED THAT THERE WAS SEVERE DIFFUSE DISEASE IN THE MID AND DISTAL LAD. APPROXIMATELY SIX MONTHS AFTER THE STENTS IMPLANTATION, THE PATIENT WAS HOSPITALIZED DUE TO THE SHORTNESS OF BREATH. THE ANGIOGRAPHY REVEALED 30% PROXIMAL LAD INSTENT RESTENOSIS AND 100% MID LAD INSTENT RESTENOSIS. IT WAS REPORTED THAT THE EVENT WAS RESOLVED.

    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 15201942

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R