BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2033298 · Received March 30, 2011

    Report

    Report Number
    3003742446-2011-00142
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    January 7, 2011
    Report Date
    March 3, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00142 AND 3003742446-2011-00143.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00142 AND 3003742446-2011-00143. INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED ANGINA AND RESTENOSIS AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, PREVIOUS PERCUTANEOUS INTERVENTION (TWICE APPROXIMATELY TWO AND A HALF YEARS PRIOR TO THE INDEX PROCEDURE), HYPERLIPIDEMIA, HYPERTENSION, MYOCARDIAL INFARCTION, GENERAL PAIN, BRADYCARDIA, AND ANXIETY. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA. THE TARGET LESIONS WERE THE DISTAL AND MID RIGHT CORONARY ARTERY (RCA). THE DISTAL RCA WAS DESCRIBED AS DE NOVO, 70% STENOSED, 9MM IN LENGTH, AND 3.25MM IN DIAMETER. THE LESION WAS DIRECT STENTED WITH A 3.0MM X 13MM CYPHER STENT AT 20ATMS AND POST-DILATED PER ROUTINE PROCEDURE WITH A 3.25MM X 12MM BALLOON AT 16 ATMS. THE MID RCA WAS DESCRIBED AS DE NOVO AND 80% STENOSED, 3.25MM IN DIAMETER AND 20MM IN LENGTH. THE LESION WAS DIRECT STENTED WITH A 3.0MM X 23MM CYPHER STENT AT 12 ATMS AND POST-DILATED PER PROCEDURE WITH A 3.25MM X 12MM BALLOON AT 16 ATMS. THE REPORTED RESIDUAL FOR BOTH STENTS WAS 0%. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND PLAVIX. AT THE THIRTY DAY FOLLOW UP, THE PATIENT REPORTED ANGINA. APPROXIMATELY TEN MONTHS POST-PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CHEST PAIN, MYOCARDIAL INFARCTION WAS RULED OUT AND THE PATIENT WAS MEDICALLY MANAGED. APPROXIMATELY THREE WEEKS LATER, THE PATIENT WAS SEEN IN THE CLINIC AND ANGIOGRAPHY WAS PERFORMED REVEALING RESTENOSIS IN THE STENT IN THE MID RCA. THE EVENT WAS TREATED WITH THE IMPLANT OF A 3.0MM X 13MM CYPHER STENT AT 14 ATMS. IT IS UNKNOWN IF THE RESTENOSIS WAS WITHIN 5MM OF THE STENT IN THE DISTAL RCA. 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. ANGINA IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING CORONARY STENTING PROCEDURES. THERE ARE PATIENT AND PROCEDURAL FACTORS WHICH MAY HAVE CONTRIBUTED TO THE EVENT. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THE PATIENT'S MEDICAL HISTORY OF CORONARY ARTERY DISEASE, SMOKING AND HYPERTENSION MAY HAVE CONTRIBUTED TO THE ANGINA AND THE RESTENOSIS. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00142 AND 3003742446-2011-00143. ADDITIONAL INFORMATION WILL BE SUBMITTED WITH 30 DAYS FROM RECEIPT. 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 15062063 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT CONFIRMED THE PATIENT DID NOT HAVE A MYOCARDIAL INFARCTION. TREATMENT FOR THE CHEST PAIN INCLUDED NITROGLYCERIN. A NON-CORDIS BALLOON CATHETER WAS USED FOR POST-DILATION DURING THE INDEX PROCEDURE. NO DISTAL DISEASE WAS LEFT UNTREATED DURING THE INDEX PROCEDURE. THE PATIENT WAS COMPLIANT WITH ANTI-PLATELET THERAPY. MEDICAL RECORDS FOR THE REVASCULARIZATION PERFORMED ELEVEN MONTHS AFTER THE INDEX PROCEDURE CONFIRMED THAT AN ANGIOGRAPHY REVEALED >= 50% RESTENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). A 3.0X13MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 14ATMS FOR 48SECS. THERE WAS NO ADVERSE EVENT TO THE PATIENT.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, THE PATIENT UNDERWENT REVASCULARIZATION OF THE CYPHER RX STENT IN THE MID RIGHT CORONARY ARTERY (RCA) ELEVEN MONTHS AFTER THE INDEX PROCEDURE. THE TARGET LESIONS WERE LOCATED IN THE MID RCA AND DISTAL RCA. THE LESION IN THE MID RCA WAS DESCRIBED AS DE NOVO, 80% STENOSED, 20MM IN LENGTH, TYPE A, NON-THROMBOSED, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.25MM IN DIAMETER AND NON-TORTUOUS. PRE-DILATION WAS NOT PERFORMED. A 3.0X23MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 12ATMS. POST-DILATION WAS PERFORMED WITH AN UNKNOWN 3.25X12MM BALLOON CATHETER AT 16ATMS. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. THE LESION IN THE DISTAL RCA WAS DESCRIBED AS DE NOVO, 70% STENOSED, 9MM IN LENGTH, TYPE A, NON-THROMBOSED, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.25MM IN DIAMETER AND NON-TORTUOUS. PRE-DILATION WAS NOT PERFORMED. A 3.0X13MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 20ATMS. THE LESION WAS POST-DILATED WITH AN UNKNOWN 3.25X12MM BALLOON CATHETER AT 16ATMS. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. THERE WAS NO POST-PROCEDURE DISSECTION. AT THE 30-DAY FOLLOW-UP VISIT, THE PATIENT REPORTED ANGINA. THE PATIENT DID NOT REPORT ANGINA AT THE 6-MONTH FOLLOW-UP VISIT. APPROXIMATELY TEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED FOR CHEST PAIN TO RULE OUT MYOCARDIAL INFARCTION (MI). UNKNOWN TREATMENT WAS GIVEN AND THE EVENT RESOLVED WITHOUT SEQUELAE. APPROXIMATELY ELEVEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT REVASCULARIZATION OF THE CYPHER RX STENT IMPLANTED IN THE MID RCA. AN UNKNOWN DRUG-ELUTING STENT WAS IMPLANTED. THE EVENT RESOLVED WITHOUT SEQUELAE. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT.

    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 15062063

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R