BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1932231 · Received December 17, 2010

    Report

    Report Number
    9616099-2010-00993
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Report Date
    November 22, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPORT OF STENT FRACTURE (B)(6) MONTHS POST IMPLANTATION OF TWO UNKNOWN CYPHER BX STENTS TO TREAT A LEFT ANTERIOR DESCENDING (LAD) LESION WAS NOTED IN (B)(4). THERE WAS NO BINARY RESTENOSIS (DEFINED AS >50%) AT THE FRACTURE SITE. THE LOCATION OF THE STENT FRACTURE AND WHETHER IT INVOLVES BOTH IMPLANTED STENTS IS UNKNOWN. THE %DIAMETER STENOSIS (DS) WAS 42% AND POPMA ET AL CLASSIFICATION WAS II ((V-FORM). THE SECOND FOLLOW UP ANGIOGRAM WAS PERFORMED (B)(6) MONTHS AFTER THE IMPLANT. THE % DS WAS 43%. AFTER THAT, THE PATIENT'S CLINICAL OUTCOME WAS EVENT FREE. THE INDICATION FOR THE INDEX PROCEDURE IN THE (B)(6) MALE WAS STABLE CORONARY ARTERY DISEASE. THE TOTAL STENTED LENGTH IN THE LAD WAS 43 MM WITH A DIAMETER OF 2.5 MM. IT WAS NEITHER AN INSTENT RESTENOSIS (ISR) NOR CHRONIC TOTAL OCCLUSION (CTO) LESION. OTHER DETAILS INCLUDING VESSEL DIAMETER, LESION LENGTH, AHA/ACC CLASSIFICATION OR PRE-PROCEDURE STENOSIS ARE NOT KNOWN. HOWEVER, IT WAS REPORTED THAT PATIENTS WITH INAPPROPRIATE VESSEL SIZE WERE EXCLUDED. THERE IS NO FURTHER INFORMATION REGARDING THE IMPLANTATION OF THE CYPHER BX STENTS. DUAL-ANTIPLATELET THERAPY WAS CONDUCTED BUT THE DETAILS OF MEDICATIONS, DOSE AND DURATION WERE UNKNOWN. THE STUDY CONCLUDED THAT LATE RESTENOSIS WAS NOT OBSERVED IN STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS DURING THE MIDTERM FOLLOW-UP AFTER STENT IMPLANTATION. IT FURTHER REPORTED THAT CLOSE FOLLOW-UP SHOULD BE PERFORMED IN PATIENTS WITH STENT FRACTURE SINCE THE RISK OF VERY LATE STENT THROMBOSIS IN STENT FRACTURE SITES AFTER MIDTERM FOLLOW-UP IS STILL UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THE STENTS REMAINS IMPLANTED AND THE LOT NUMBERS ARE NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. POSSIBLE FACTORS CONTRIBUTING TO STENT FRACTURES ARE LONG LESIONS, OVERLAPPING STENTS, AND CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. LONGER AND/OR OVERLAPPING STENTS OFTEN STRAIGHTEN OUT THE VESSEL AND MAY BE SUBJECTED TO MORE FORCE AND BENDING MOVEMENTS BECAUSE OF THIS STRAIGHTENING ACTION. IN ADDITION TO PROGRESSION OF EXISTING DISEASE, 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 LIMITED PROCEDURAL INFORMATION IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING THE REPORTED EVENT; HOWEVER, PROCEDURAL AND VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. PLEASE NOTE THAT ADDITIONAL REGARDING THE EVENTS IS STILL BEING REQUESTED, THEREFORE, ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. THIS IS ONE OF TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT #S 9616099-2010-00992 AND 9616099-2010-00993.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THAT ONLY ONE OF THE TWO STENTS IMPLANTED IN THE PATIENT HAD FRACTURED, THEREFORE, THE EVENT IS NOW CONSIDERED NOT REPORTABLE FOR THIS PRODUCT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND IS THEREFORE NOT AVAILABLE FOR EVALUATION. PLEASE NOTE THAT THE CATALOG NUMBER IS NOT KNOWN. THIS PRODUCT IS NOT DISTRIBUTED IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. THE EVENT DATE IS UNKNOWN. THIS IS ONE OF TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT #S 9616099-2010-00992 AND 9616099-2010-00993. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM LITERATURE. AMERICAN HEART JOURNAL 2010;160:775.E1-775.E9, "SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION." THE LITERATURE IS FROM (B)(6) HOSPITAL AND (B)(6) MEDICAL UNIVERSITY. THE PATIENT WAS ADMITTED TO THE INDEX PROCEDURE WITH STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE TARGET LESION WAS NEITHER AN IN-STENT RESTENOSIS (ISR) NOR A CTO LESION. TWO CYPHER BX STENTS OF UNKNOWN INDIVIDUAL LENGTH WERE IMPLANTED AT THE TARGET LESION. THE TOTAL STENT LENGTH WAS 43MM AND THE DIAMETER OF THE STENT WAS 2.5MM. THE FIRST FOLLOW-UP ANGIOGRAM WAS PERFORMED 6-9 MONTHS AFTER THE IMPLANT AND REVEALED STENT FRACTURE, BUT NO BINARY RESTENOSIS WAS OBSERVED AT THE FRACTURE SITE. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE DIAMETER STENOSIS (DS) OF THE TARGET LESION WAS 42%. THE POPMA ET. AL. CLASSIFICATION WAS II. THE SECOND SCHEDULED FOLLOW UP ANGIOGRAM WAS PERFORMED >15 MONTHS AFTER SES IMPLANTATION AND REVEALED 43% DIAMETER STENOSIS.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R