BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1933494 · Received December 20, 2010

    Report

    Report Number
    9616099-2010-01006
    Event Type
    Injury
    Date Received
    December 20, 2010
    Report Date
    December 9, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND IS THEREFORE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. PLEASE NOTE THE EVENT DATE IS UNKNOWN. THE CATALOG NUMBER IS UNKNOWN. THE CATALOG NUMBER ENTERED REPRESENTS AN UNKNOWN CYPHER SELECT PLUS. THE DEVICE IS NOT DISTRIBUTED IN THE UNITES STATES, HOWEVER, IT IS SIMILAR TO THE CYPHER SIROLIMUS-ELUTING CORONARY STENT DISTRIBUTED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED FROM A JOURNAL ARTICLE: DAVLOUROS PA, ET. AL., FLAT PANEL DIGITAL DETECTOR CINEFLUOROSCOPY LATE FOLLOWING SES OR BMS IMPLANTATION FOR DETECTION OF CORONARY STENT FRACTURE IN ASYMPTOMATIC PATIENTS, INT J CARDIOL (2010), DOI:10.1016/J.IJCARD.2010.11.002, (CASE 3) REPORTED THAT AT FOLLOW-UP 45.5+/- 15.7MONTHS POST STENTING WITH A CYPHER SIROLIMUS-ELUTING STENT (SES) A TYPE 2 STENT FRACTURE WITH 55% STENOSIS WAS OBSERVED IN THE ASYMPTOMATIC PATIENT. THERE WAS NO PERCUTANEOUS CORONARY INTERVENTION (PCI) PERFORMED DURING THE FOLLOW UP. TYPE 2 FRACTURE WAS DEFINED AS INCOMPLETE TRANSVERSE STRUT FRACTURE RESULTING IN A V-SHAPED HORIZONTAL SEPARATION OF THE STRUTS WITHOUT DISCONTINUITY AT ONE EDGE OF THE STENT. THE ARTICLE INDICATED A MINIMAL LUMEN DIAMETER (MLD) OF 1.95, AND REFERENCE DIAMETER (RD) OF 2.50 POST IMPLANTATION, WITH A % STENOSIS POST IMPLANTATION OF 16. THE MLD AT FOLLOW-UP WAS 1.17 WITH A RD OF 2.72 AT FOLLOW-UP. ADDITIONAL INFORMATION REPORTED THAT THE TARGET SITE WAS AN ECCENTRIC RIGHT CORONARY ARTERY (RCA) LESION. PREDILATION WAS PERFORMED AT 12-14 ATM AND THE 2.5X28 CYPHER SELECT STENT (B)(4) WAS DEPLOYED AT 18 ATM. THE INSTRUCTIONS FOR USE OUTLINES THAT THE RATED BURST IS 16 ATM. THE STENT WAS POST-DILATED AT 18 ATM. THE RESIDUAL STENOSIS WAS 0%. THE STENT WAS NOT IN A LOCATION WHERE THE VESSEL WAS INTRAMYOCARDIAL. THERE WAS NO DISSECTION. THE STATUS OF THE PATIENT IS OKAY. THE ARTICLE ALSO REPORTED THAT THE FRACTURED CYPHER STENTS OBSERVED IN THIS STUDY COMPARED TO THOSE THAT WERE NOT FRACTURED WERE LONGER STENTS MORE FREQUENTLY LOCATED IN THE RCA IN A LESION AND MORE FREQUENTLY LOCATED IN AN ANGLED AREA IN THE MIDDLE OF THE VESSEL AND OCCURRED MORE IN TYPE B2 AND C LESIONS. THE PRODUCT IS 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 R1203233 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT R1203233. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. A DHR REVIEW WAS REQUESTED TO (B)(4) FOR PART NUMBER: 01A5994 STENT LOT NUMBER: 4024606 AND THE RESULTS INDICATE THAT ALL STENTS SHIPPED MEETS SPECIFIED RELEASE REQUIREMENTS. POSSIBLE FACTORS CONTRIBUTING TO STENT FRACTURES ARE LONG LESIONS, CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. TYPICALLY THE RIGHT CORONARY ARTERY (RCA) HAS MORE MOTION THAN OTHER CORONARY ARTERIES. STENTS OFTEN STRAIGHTEN OUT THE VESSEL AND MAY BE SUBJECTED TO MORE FORCE AND BENDING MOVEMENTS BECAUSE OF THIS STRAIGHTENING ACTION. THE MECHANISM OF RESTENOSIS AFTER STENT FRACTURE MAY BE RELATED TO LOSS OF THE MECHANICAL SCAFFOLDING OF THE STENT AS WELL AS TO INTIMAL HYPERPLASIA AT THE SITE OF VESSEL WALL INJURY. BASED ON THE AVAILABLE INFORMATION, VESSEL/LESION CHARACTERISTICS RESULTING IN MECHANICAL STRESS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FROM A JOURNAL ARTICLE: DAVLOUROS PA, ET. AL., FLAT PANEL DIGITAL DETECTOR CINEFLUOROSCOPY LATE FOLLOWING SES OR BMS IMPLANTATION FOR DETECTION OF CORONARY STENT FRACTURE IN ASYMPTOMATIC PATIENTS, INT J CARDIOL (2010), DOI:10.1016/J.IJCARD.2010.11.002, REPORTED THAT A PATIENT TREATED WITH A CYPHER SIROLIMUS-ELUTING STENT (SES) HAD A TYPE 2 STENT FRACTURE WITH 55% STENOSIS AT FOLLOW-UP. THE PATIENT WAS ASYMPTOMATIC. THERE WAS NO PERCUTANEOUS CORONARY INTERVENTION (PCI) PERFORMED DURING THE FOLLOW UP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED; THE STENT WAS PRE-DILATED AT 12-14 ATM. THE TARGET LESION WAS THE RIGHT CORONARY ARTERY (RCA). THERE WAS NO POSSIBILITY OF DISSECTION. THE STENT DEPLOYMENT PRESSURE WAS 18 ATM. THE STENT WAS POST-DILATED AT 18 ATM. THE RESIDUAL STENOSIS WAS 0%. THE STENT WAS NOT IN A LOCATION WHERE THE VESSEL WAS INTRAMYOCARDIAL. THE STATUS OF THE PATIENT IS OKAY.

    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 NA R1203233

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L