BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1852889 · Received October 5, 2010

    Report

    Report Number
    9616099-2010-00750
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 6, 2005
    Report Date
    September 10, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO TREAT THE THROMBUS, ASPIRATION AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) WERE CONDUCTED. IT WAS REPORTED THAT PER THE LATEST FOLLOW UP WITH THE PATIENT, APPROXIMATELY SIX MONTHS AFTER THE EVENT, THE PATIENT WAS IN STABLE CONDITION. THE PHYSICIAN INDICATED THAT THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS BECAUSE THE OVERLAPPED PORTION OF THE CYPHER BX IMPLANTED IN THE TARGET LESION WAS UNDER-DILATED. INTRA AND POST-PROCEDURE: ASPIRIN 200MG/DAY AND TICLOPIDINE HYDROCHLORIDE 200MG/DAY. THE PRODUCT, CYPHER (B)(4), IS NOT DISTRIBUTED IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES, CYPHER SIROLIMUS-ELUTING CORONARY STENT. THE PRODUCT REMAINS IMPLANTED AND IS THEREFORE NOT AVAILABLE FOR EVALUATION. 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 I0405144 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 6 UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT I0405144. ADDITIONAL INFORMATION WAS REQUESTED TO THE COATING SITE FOR CORONARY ARTERY THROMBOSIS. THE INVESTIGATION REVEALED THAT NO NONCONFORMANCES WERE ISSUED DURING THE COATING PROCESS, AND THAT NO ANOMALIES WERE FOUND FOR THE LOT INVOLVED. THIS IS ONE OF TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 9616099-2010-00750 AND 9616099-2010-00752. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED VIA THE (B)(4) STUDY THAT ONE DAY POST IMPLANTATION OF TWO OVERLAPPING CYPHER BX STENTS TO TREAT A MID LEFT ANTERIOR DESCENDING ARTERY LESION (LAD) THE PATIENT DEVELOPED AN ST-ELEVATED MYOCARDIAL INFARCTION. CORONARY ANGIOGRAPHY WAS CONDUCTED AND THROMBUS WAS OBSERVED INSIDE THE CYPHER BX IMPLANTED AT (B)(6). TO TREAT THE THROMBUS, ASPIRATION AND POBA WERE CONDUCTED. THE PHYSICIAN REPORTED THAT THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS BECAUSE THE OVERLAPPED PORTION OF THE CYPHER BX IMPLANTED AT THE MID LAD WAS UNDER-DILATED. AT INDEX PROCEDURE PERCUTANEOUS CORONARY INTERVENTION FOR TREATMENT OF THE MID LAD WAS CONDUCTED AS AN EMERGENT CASE DUE TO ACUTE CORONARY SYNDROME. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH UNSTABLE ANGINA PECTORIS. IT IS UNKNOWN IF PRE-DILATION WAS CONDUCTED. THE FIRST CYPHER BX (2.5/23MM) WAS IMPLANTED AT 20ATM (INFLATION TIME UNKNOWN) AT THE DISTAL PORTION OF THE TARGET LESION. THIS IS GREATER THAT THE RATED BURST OF 16 ATM, WHICH AS OUTLINED IN THE IFU SHOULD NOT BE EXCEEDED. THEN, THE SECOND CYPHER BX (3.0/28MM) WAS IMPLANTED AT 16ATM (INFLATION TIME UNKNOWN) PROXIMAL TO THE FIRST CYPHER BX, OVERLAPPING IT. POST-DILATION WAS CONDUCTED WITH A 2.75MM BALLOON; DETAILS ARE UNKNOWN. THE RESIDUAL % OF STENOSIS WAS UNKNOWN. TIMI FLOW BEFORE AND AFTER THE PROCEDURE IS NOT UNKNOWN. IVUS WAS CONDUCTED AFTER INITIAL STENT PLACEMENT WITH REPORTED SATISFACTORY RESULTS. AN UNKNOWN DOSE OF HEPARIN WAS ADMINISTERED. IT IS UNKNOWN IF ACT WAS MEASURED. ANTIPLATELET THERAPY INCLUDED ASPIRIN 200MG/DAY AND TICLOPIDINE HYDROCHLORIDE SINCE INDEX PROCEDURE. THE PATIENT'S STATUS WAS STABLE SIX MONTHS POST PROCEDURE. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT I0405144 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WAS REQUESTED TO THE COATING SITE FOR CORONARY ARTERY THROMBOSIS. THE INVESTIGATION REVEALED THAT NO NONCONFORMANCES WERE ISSUED DURING THE COATING PROCESS, AND THAT NO ANOMALIES WERE FOUND FOR THE LOT INVOLVED. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO EXCURSIONS WERE FOUND FOR LOT I0405144. THE STENTS REMAIN IMPLANTED AND THEREFORE ARE NOT AVAILABLE FOR ANALYSIS. THROMBOTIC EVENTS AND MYOCARDIAL INFARCTION ARE A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION. BASED ON THE AVAILABLE INFORMATION AND REPORT THAT POST STENT IMPLANTATION IVUS WAS SATISFACTORY, NO CONCLUSION CAN BE MADE REGARDING THE POSSIBLE UNDER-EXPANSION. IT IS NOT KNOWN IF PREDILATION WAS CONDUCTED. PROCEDURAL FACTORS AND VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED. THIS PATIENT'S EMERGENT PRESENTATION WITH ACUTE CORONARY SYNDROME AND UNSTABLE ANGINA PUTS HIM AT A GREATER RISK FOR MAJOR ADVERSE EVENTS AND POSSIBLY IN A HYPERCOAGULABLE STATE. THIS ALONG WITH THE REPORT THAT THE EVENT MAY HAVE BEEN POSSIBLY BEEN DUE TO UNDER-DILATION AT THE OVERLAPPED AREA OF THE STENTS, ARE FACTORS THAT MAY HAVE CONTRIBUTED TO THE POST PROCEDURE THROMBUS AND MYOCARDIAL INFARCTION. THERE IS NO INDICATION OF A RELATIONSHIP TO THE DEVICE MANUFACTURING PROCESS; PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENTS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. THIS IS ONE OF TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 9616099-2010-00750 AND 9616099-2010-00752.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS ADMITTED EMERGENTLY WITH UNSTABLE ANGINA PECTORIS AND A TYPE C, DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION LENGTH WAS APPROXIMATELY 45MM AND THE VESSEL DIAMETER WAS APPROXIMATELY 2.5 - 3.0 MM. THE PATIENT WAS ADMITTED EMERGENTLY WITH ACUTE CORONARY SYNDROME FOR THE INDEX PROCEDURE. IT IS UNKNOWN IF PRE-DILATION WAS CONDUCTED. A 2.5 X 23MM CYPHER BX WAS IMPLANTED AT 20ATM (INFLATION TIME UNKNOWN) AT THE DISTAL PORTION OF THE TARGET LESION. THEN, THEN A 3.0 X 28MM CYPHER BX WAS IMPLANTED AT 16ATM (INFLATION TIME UNKNOWN) PROXIMAL AND OVERLAPPING THE 1ST CYPHER BX. POST-DILATION WAS CONDUCTED WITH A 2.75MM BALLOON, BUT DETAILS WERE UNKNOWN. THE RESIDUAL STENOSIS WAS UNKNOWN. IVUS WAS USED AFTER INITIAL PLACEMENT OF THE STENT AND WAS SATISFACTORY. THE DAY AFTER THE INDEX PROCEDURE, THE PATIENT DEVELOPED ST-ELEVATED MYOCARDIAL INFARCTION (MI). CORONARY ANGIOGRAPHY (CAG) WAS CONDUCTED AND THROMBUS WAS OBSERVED INSIDE THE CYPHER BX IMPLANTED AT IN THE MID LAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO I0405144

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization HEPARIN