BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2031589 · Received March 28, 2011

    Report

    Report Number
    9616099-2011-00206
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    January 17, 2011
    Report Date
    March 1, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT A (B)(6) MALE PATIENT HAD A STENT FRACTURE AND RESTENOSIS APPROXIMATELY A YEAR AND EIGHT MONTHS AFTER IMPLANTATION OF A CYPHER STENT. THE INDICATION FOR THE INDEX PROCEDURE WAS EMERGENT. CORONARY ANGIOGRAPHY SHOWED A RIGHT DOMINANT CORONARY, 80% STENOSIS IN THE PROXIMAL-TO-MIDDLE LAD AND THE PROXIMAL-LCX WAS OCCLUDED. TIMI FLOW WAS GRADE 0. THE PATIENT HAD A CYPHER SELECT PLUS 2.75 X 23 MM STENT IMPLANTED IN THE PROXIMAL CIRCUMFLEX TARGET LESION. APPROXIMATELY A WEEK LATER, THE PATIENT UNDERWENT AN ELECTIVE PROCEDURE. THE PROXIMAL-RCA HAD 20% STENOSIS, MID-RCA HAD 75% STENOSIS, THE PROXIMAL-LAD HAD 80% STENOSIS, (B)(4) HAD 30% STENOSIS, PROXIMAL-LCX WAS 50% STENOSIS, TIMI FLOW WAS GRADE 3. A CRB23350 AND CRB28300 WERE IMPLANTED AT RCA AND LAD. A YEAR AND EIGHT MONTHS AFTER THE INDEX PROCEDURE, ANGIOGRAPHY WAS DONE DUE TO ANGINA AND THE PREVIOUSLY IMPLANTED CYPHER STENT WAS NOTED TO BE FRACTURED/SEPARATED. THE PROXIMAL-LCX INTIMA WAS NOT SMOOTH, 30% IN-STENT RESTENOSIS WAS OBSERVED. NO IN-STENT THROMBOSIS OR ANEURYSM WAS OBSERVED. STENT STRUT WAS NOT CONTINUOUSLY CONNECTED. TIMI FLOW WAS GRADE 3. MEDICATION THERAPY, SO FAR NO RE-PCI WAS CONDUCTED. THE PROXIMAL-TO-MIDDLE RCA WAS ATHEROSCLEROSIS, PROXIMAL-RCA WAS 20% STENOSIS. THE STENT AT PROXIMAL-TO-MIDDLE RCA WAS SMOOTH. NO IN-STENT RESTENOSIS OR IN-STENT THROMBOSIS OR ANEURYSM WAS OBSERVED. TIMI FLOW WAS GRADE 3. THE LAD OSTIAL WAS 40% STENOSIS. THE STENT AT PROXIMAL-LAD WAS SMOOTH. NO IN-STENT RESTENOSIS OR IN-STENT THROMBOSIS OR ANEURYSM WAS OBSERVED. TIMI FLOW WAS GRADE 3. NO RE-PCI WAS CONDUCTED. THE PATIENT WAS TREATED MEDICALLY. THREE (3) CDS WERE RECEIVED WITH PROCEDURAL FILMS. AN INDEPENDENT CARDIOLOGIST FILM REVIEW REPORT INDICATED THAT: "THE CASE INVOLVED A PATIENT WITH MULTI-VESSEL DISEASE WITH COMPLETE OCCLUSION OF THE CIRCUMFLEX TREATED WITH A CYPHER STENT DURING THE INDEX PROCEDURE. THE PATIENT CAME BACK IN A STAGED FASHION AND HAD THE LAD DIAGONAL AND RCA STENTED. THE PATIENT APPARENTLY DEVELOPED RECURRENT ANGINA AND REPEAT CATHETERIZATION REVEALED STENT FRACTURE. THE PATIENT HAD A COMPLETE OCCLUSION OF A SMALL TO MODERATE CALIBER CIRCUMFLEX. THE LONG STENTS WERE PLACED IN HYPER-MOBILE AND ACUTELY ANGULATED SEGMENTS AND THIS IS WHERE THE STENT FRACTURE OCCURRED. THERE WAS MODERATE DISPLACEMENT WITH RE-STENOSIS NOTED. THESE FILMS REPRESENT LONG STENTS PLACED IN A TOTAL OCCLUSION WITH MARKED ANGULATION AND HYPER-MOBILITY OF THE VESSEL. THESE MECHANICAL FACTORS NO DOUBT PLAYED A ROLE IN THE FRACTURE OF THE STENT. WHEN THERE IS SIGNIFICANT DISPLACEMENT, RE-STENOSIS RATES ARE INCREASED AND THAT WAS PRESENT IN THIS PARTICULAR CASE. THERE WERE NOT HEAVY CALCIFICATIONS IN THE VESSEL OF NOTE AND THE PATIENT APPARENTLY HAD NO UNTOWARD SEQUEL." THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. 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. RECENTLY, SES FRACTURE HAS BEEN RECOGNIZED AS A NEW POTENTIAL MECHANISM OF RESTENOSIS. POSSIBLE DISPOSING FACTORS OF STENT FRACTURE ARE OVERLAPPING STENTS, CARDIAC MOTION AND VESSEL ANGULATIONS/TORTUOSITY FOR THE NATIVE CORONARY ARTERY. THE CAUSE OF COMPLETE SES FRACTURE IN THE PRESENT CASE WAS MOST LIKELY MECHANICAL STRESSES RESULTING FROM MARKED ANGULATION AND HYPER-MOBILITY. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE PATIENT HAD A CYPHER SELECT PLUS 2.75 X 23 MM STENT IMPLANTED IN THE PROXIMAL CIRCUMFLEX TARGET LESION DURING THE INDEX PROCEDURE. APPROXIMATELY TWENTY MONTHS AFTER THE INDEX PROCEDURE CORONARY ANGIOGRAPHY WAS DONE DUE TO ANGINA AND THE PREVIOUSLY IMPLANTED CYPHER STENT WAS NOTED TO BE FRACTURED/SEPARATED. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS IN STABLE CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 14053864

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| R