BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1850286 · Received October 1, 2010

    Report

    Report Number
    9616099-2010-00729
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    April 27, 2008
    Report Date
    September 8, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE THROMBOSIS, THE PATIENT WAS TAKING ASPIRIN AND CILOSTAZOL. ADMINISTRATION OF TICLOPIDINE HYDROCHLORIDE WAS DISCONTINUED DUE TO HEPATIC DYSFUNCTION APPROXIMATELY TWO WEEKS PRIOR TO THE EVENT AND THE PATIENT BEGAN TAKING CILOSTAZOL. PHYSICIAN'S COMMENT: THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS THE EFFECT OF THE STENT FRACTURE. THE LOT NUMBER FOR THIS DEVICE WAS EITHER I0106147 OR I0106199. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00729, 9616099-2010-00730 AND 9616099-2010-00731.

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED ON (B)(4) 2010 THAT THE INITIAL ALERT DATE FOR THIS EVENT WAS (B)(4) 2010 INSTEAD OF (B)(4) 2010 AS PREVIOUSLY REPORTED. (B)(4) CYPHER PRODUCT (CJS) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS). THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00729, 9616099-2010-00730 AND 9616099-2010-00731. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    CONCLUSION: AS REPORTED VIA THE (B)(4) STUDY, A PATIENT EXPERIENCED AN ST ELEVATION MYOCARDIAL INFARCTION (MI), STENT THROMBOSIS AND STENT FRACTURE. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR PREVIOUS PERCUTANEOUS INTERVENTION, HYPERTENSION AND SMOKING. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED A 55MM LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE AHA/ACC CLASSIFICATION WAS TYPE C. THE VESSEL DIAMETER WAS 2.5 TO 3.0MM. IT WAS UNKNOWN IF THE LESION WAS PRE-DILATED. A 2.5 X 28MM CYPHER BX WAS IMPLANTED AT 16ATM AT THE DISTAL MOST PORTION OF THE LESION FOLLOWED BY A 2.5 X 18MM CYPHER BX IMPLANTED AT 18ATM WITH OVERLAP AND A 3.0 X 18MM IMPLANTED AT 15ATM WITH OVERLAP IN THE MOST PROXIMAL PORTION OF THE LESION. IT WAS UNKNOWN IF THE STENTS WERE POST-DILATED, AND THE PERCENTAGE OF RESIDUAL STENOSIS WAS UNKNOWN. IVUS WAS NOT CONDUCTED. APPROXIMATELY TWO YEARS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED AN ST-ELEVATION MI. ANGIOGRAPHY SHOWED THROMBUS INSIDE THE CYPHER STENTS AND A STENT FRACTURE (LOCATION UNKNOWN). THE THROMBUS WAS TREATED WITH ASPIRATION AND THE PATIENT WAS SUPPORTED WITH AN INTRA-AORTIC BALLOON PUMP. THERE WAS NO REPORTED TREATMENT OF THE STENT FRACTURE. AT THE TIME OF THE THROMBOSIS, THE PATIENT WAS TAKING ASPIRIN AND CILOSTAZOL. ADMINISTRATION OF TICLOPIDINE HYDROCHLORIDE WAS DISCONTINUED DUE TO HEPATIC DYSFUNCTION APPROXIMATELY TWO WEEKS PRIOR TO THE EVENT AND THE PATIENT BEGAN TAKING CILOSTAZOL. PHYSICIAN'S COMMENT: THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS THE EFFECT OF THE STENT FRACTURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED THE TWO POSSIBLE LOTS THAT MAY HAVE BEEN ASSOCIATED WITH THIS COMPLAINT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. STENT THROMBOSIS AND MYOCARDIAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. WHILE NOT OBSERVED IN THE (B)(4) CLINICAL TRIALS THAT SUPPORTED THE CYPHER STENT PMA, STENT FRACTURES ARE UNCOMMON EVENTS BUT HAVE BEEN OBSERVED IN LONG STENTED SEGMENTS INCLUDING THOSE IN WHICH OVERLAPPING STENTS HAVE BEEN USED. THEY HAVE BEEN OBSERVED IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. IN THE CYPHER STENT, THEY HAVE BEEN REPORTED MOST OFTEN IN CERTAIN LESION SUBGROUPS IN WHICH SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED. REVIEW OF THE LIMITED INFORMATION SUGGESTS THAT VESSEL/LESION CHARACTERISTICS (LONG AND OVERLAPPING STENTS) MAY HAVE CONTRIBUTED TO THE EVENT OF STENT FRACTURE. THE PATIENT'S MEDICAL HISTORY OF SMOKING AND HYPERTENSION OR THE RECENT CHANGE IN ANTI-PLATELET THERAPY MAY HAVE ALSO CONTRIBUTED TO THE REPORTED MI AND THROMBOSIS. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED. (B)(4) CYPHER PRODUCT (CJS) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS). THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00729, 9616099-2010-00730 AND 9616099-2010-00731.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(6) STUDY, A PATIENT EXPERIENCED AN ST ELEVATION MYOCARDIAL INFARCTION (MI), STENT THROMBOSIS AND STENT FRACTURE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED A 55MM LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE AHA/ACC CLASSIFICATION WAS TYPE C. THE VESSEL DIAMETER WAS 2.5 TO 3.0MM. IT WAS UNKNOWN IF THE LESION WAS PRE-DILATED. A 2.5 X 28MM CYPHER BX WAS IMPLANTED AT 16ATM AT THE DISTAL MOST PORTION OF THE LESION FOLLOWED BY A 2.5 X 18MM CYPHER BX IMPLANTED AT 18ATM WITH OVERLAP AND A 3.0 X 18MM IMPLANTED AT 15ATM WITH OVERLAP IN THE MOST PROXIMAL PORTION OF THE LESION. IT WAS UNKNOWN IF THE STENTS WERE POST-DILATED, AND THE PERCENTAGE OF RESIDUAL STENOSIS WAS UNKNOWN. IVUS WAS NOT CONDUCTED. APPROXIMATELY TWO YEARS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED AN ST-ELEVATION MI. ANGIOGRAPHY SHOWED THROMBUS INSIDE THE CYPHER STENTS AND A STENT FRACTURE (LOCATION UNKNOWN). THE THROMBUS WAS TREATED WITH ASPIRATION AND THE PATIENT WAS SUPPORTED WITH AN INTRA-AORTIC BALLOON PUMP. THERE WAS NO REPORTED TREATMENT OF THE STENT FRACTURE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R ASPIRIN 200MG DAILY AND CILOSTAZOL