BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1919728 · Received December 10, 2010

    Report

    Report Number
    9616099-2010-00930
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    June 28, 2008
    Report Date
    November 17, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED (B)(4) 2010. AT THE TIME OF STENT IMPLANTATION, THE LESION WAS 20MM IN LENGTH. THE STENT WAS IMPLANTED IN AN ACTIVELY MOVING SEGMENT OF THE ARTERY WHERE THE VESSEL WAS INTRAMYOCARDIAL WITH MYOCARDIAL BRIDGING. THE CYPHER STENTS WERE DEPLOYED AT 16ATM WITH THE TOTAL STENTED SEGMENT BEING 23MM IN LENGTH. THE STENTS WERE NOT POST DILATED. THE FRACTURE AND RESTENOSIS ONLY INVOLVED ONE OF THE RCA STENTS (THE RESTENOSIS WAS GREATER THAN 5MM FROM THE SECOND STENT). INFORMATION ABOUT CATALOG AND LOT NUMBERS WAS NOT AVAILABLE. COMPLAINT CONCLUSION: A LITERATURE ARTICLE REPORTED THAT A PATIENT EXPERIENCED A STENT FRACTURE WITH COMPLETE DISCONTINUITY OF THE STENT STRUTS AND MODERATE STENOSIS APPROXIMATELY TWO YEARS AND ONE MONTH AFTER CYPHER SELECT IMPLANTATION. THE ARTICLE WAS ENTITLED CORONARY STENT FRACTURE DETECTED BY MULTIDETECTOR COMPUTED TOMOGRAPHY, AND WAS PUBLISHED IN INT J CARDIOVASC IMAGING (2010) 26:729'730, DOI 10.1007/S10554-010-9624-1. ON (B)(4), 2006, ANGIOGRAPHY WAS PERFORMED WHICH SHOWED A 70% STENOSIS IN THE RIGHT CORONARY ARTERY (RCA). THREE CYPHER SELECT STENTS WERE IMPLANTED, ONE IN THE LEFT ANTERIOR DESCENDING (LAD) AND 2 IN THE RCA. AT THE TIME OF STENT IMPLANTATION, THE LESION WAS 20MM IN LENGTH. THE STENT WAS IMPLANTED IN AN ACTIVELY MOVING SEGMENT OF THE ARTERY WHERE THE VESSEL WAS INTRAMYOCARDIAL WITH MYOCARDIAL BRIDGING. THE CYPHER STENTS WERE DEPLOYED AT 16ATM WITH THE TOTAL STENTED SEGMENT BEING 23MM IN LENGTH. THE STENTS WERE NOT POST DILATED. THE FRACTURE AND RESTENOSIS ONLY INVOLVED ONE OF THE RCA STENTS (THE RESTENOSIS WAS GREATER THAN 5MM FROM THE SECOND STENT). INFORMATION ABOUT CATALOG AND LOT NUMBERS WAS NOT AVAILABLE. THE STENOSIS WAS COMPLETELY ABOLISHED AFTER PCI. ON (B)(6), 2008 CT ANGIOGRAPHY WAS PERFORMED BECAUSE OF ATYPICAL CHEST PAIN. A FRACTURE OF THE RCA STENT WAS CLEARLY SHOWN. ANGIOGRAPHY DEMONSTRATED A Z SHAPED BENDING AND THE FLUOROSCOPY CONFIRMED A COMPLETE DISCONTINUITY OF THE STENT STRUTS WITH MODERATE STENOSIS. ANOTHER DRUG ELUTING STENT OF 3.0X15 MM (ENDEAVOR, MEDTRONIC, (B)(4)) WAS INSERTED OVERLAPPING THE FRACTURED STENT. THERE IS NO STERILE LOT NUMBER AVAILABLE THUS NO DHR COULD BE PERFORMED. IN THIS CASE THE STENT WAS IMPLANTED TO TREAT A STENOSIS IN AN AREA OF MYOCARDIAL BRIDGING. MYOCARDIAL BRIDGING OCCURS WHEN THE CORONARY ARTERY IS LOCATED UNDERNEATH A SECTION OF THE MYOCARDIAL MUSCLE FIBERS AND DURING MUSCLE CONTRACTION THE ARTERY BECOMES COMPRESSED AND POSSIBLY OCCLUDED. STENT IMPLANTATION IN AREAS OF MYOCARDIAL BRIDGING IS NOT STANDARD PRACTICE, BECAUSE OF THE DYNAMIC FORCES EXPERIENCED BY THE ARTERY STRUCTURES WITHIN THE MUSCLE BRIDGE. STENT FRACTURES HAVE BEEN OBSERVED IN VESSEL SEGMENTS THAT UNDERGO SIGNIFICANT MOTION. FRACTURE OF THE STENT, DUE TO STRUCTURAL FATIGUE, MAY HAVE LEAD TO VESSEL INTIMA DAMAGE AND EPITHELIAL OVERGROWTH WITH RESTENOSIS. REVIEW OF THE INFORMATION SUGGESTS THAT TARGET LESION / VESSEL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. CYPHER SELECT PRODUCT (B)(4) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CYPHER SELECT PRODUCT (CRA/CRB/CJB) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS).

    Description of Event or Problem · 1

    A LITERATURE ARTICLE REPORTED THAT A PATIENT EXPERIENCED A STENT FRACTURE WITH COMPLETE DISCONTINUITY OF THE STENT STRUTS AND MODERATE STENOSIS APPROXIMATELY TWO YEARS AND ONE MONTH AFTER CYPHER SELECT IMPLANTATION. THE ARTICLE WAS ENTITLED "CORONARY STENT FRACTURE DETECTED BY MULTIDETECTOR COMPUTED TOMOGRAPHY",AND WAS PUBLISHED IN INT J CARDIOVASC IMAGING (2010) 26:729-730, DOI 10.1007/S10554-010-9624-1. ON (B)(6) 2006, ANGIOGRAPHY WAS PERFORMED WHICH SHOWED A 70% STENOSIS IN THE RIGHT CORONARY ARTERY (RCA). THREE CYPHER SELECT STENTS WERE IMPLANTED, ONE IN THE LEFT ANTERIOR DESCENDING (LAD) AND 2 IN THE RCA. THE STENOSIS WAS COMPLETELY ABOLISHED AFTER PCI. ON (B)(6) 2008, CT ANGIOGRAPHY WAS PERFORMED BECAUSE OF ATYPICAL CHEST PAIN. A FRACTURE OF THE RCA STENT WAS CLEARLY SHOWN. ANGIOGRAPHY DEMONSTRATED A Z SHAPED BENDING AND THE FLUOROSCOPY CONFIRMED A COMPLETE DISCONTINUITY OF THE STENT STRUTS WITH MODERATE STENOSIS. ANOTHER DRUG ELUTING STENT OF 3.0X15 MM (ENDEAVOR, MEDTRONIC, USA) (DES) WAS INSERTED OVERLAPPING THE FRACTURED STENT.

    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 55 YR Hospitalization| R