BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1920426 · Received December 10, 2010

    Report

    Report Number
    9616099-2010-00940
    Event Type
    Injury
    Date Received
    December 10, 2010
    Report Date
    November 22, 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

    THE COMPLAINT CONCLUSION BELOW WAS CORRECTED TO INDICATE THAT ONLY ONE OF THE THREE STENTS WAS FRACTURED. AS REPORTED VIA THE AMERICAN HEART JOURNAL (2010;160:775.E1-775.E9) ARTICLE ENTITLED 'SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION' A PATIENT EXPERIENCED A DISLOCATED STENT FRACTURE WITH RESTENOSIS 6-9 MONTHS AFTER STENT IMPLANTATION, AND LATER HAD ANOTHER RESTENOSIS AT THE AREA OF THE STENT FRACTURE. THIS CASE IS 8TH OF 29 EVENTS. THE PATIENT WAS A (B)(6) FEMALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS LEFT ANTERIOR DESCENDING (LAD), BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NEITHER AN IN-STENT RESTENOSIS NOR A CHRONIC TOTAL OCCLUSION. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, THREE CYPHER BX (SIZE AND LOT UNKNOWN) WERE IMPLANTED. THE TOTAL STENT LENGTH WAS 56MM AND THE DIAMETER OF THE STENT WAS 3.0MM; HOWEVER, THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. AT THE FIRST FOLLOW-UP ANGIOGRAPHY SIX TO NINE MONTHS AFTER STENT IMPLANTATION, THE STENT WAS NOTED TO BE FRACTURED AND DISPLACED WITH 56% RESTENOSIS. THE PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY INITIALLY, BUT LATER HAD THE IMPLANTATION OF A PACLITAXEL-ELUTING STENT DUE TO FURTHER RESTENOSIS. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ONLY ONE OF THE THREE STENTS WAS FRACTURED. REOCCLUSION/RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. STENT DAMAGE/DEFORMATION AND RESTENOSIS/REOCLUSSION ARE KNOWN ADVERSE EVENTS INDICATED IN THE IFU. WHILE NOT OBSERVED IN THE PIVOTAL 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. BASED ON THE LIMITED PROCEDURAL INFORMATION AND WITHOUT FILMS, IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING THE REPORTED EVENTS. HOWEVER, VESSEL/LESION CHARACTERISTICS AND PROCEDURAL FACTORS ARE LIKELY CONTRIBUTING FACTORS. THERE IS NO INDICATION THAT THE EVENTS ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00938, 9616099-2010-00939 AND 9616099-2010-00940. (B)(4) CYPHER PRODUCT (CJS) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00938, 9616099-2010-00939 AND 9616099-2010-00940. (B)(4) CYPHER PRODUCT IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011: ONLY ONE OF THE THREE STENTS WAS FRACTURED. AS REPORTED VIA THE AMERICAN HEART JOURNAL (2010;160:775.E1-775.E9) ARTICLE ENTITLED 'SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION' A PATIENT EXPERIENCED A DISLOCATED STENT FRACTURE WITH RESTENOSIS 6-9 MONTHS AFTER STENT IMPLANTATION, AND LATER HAD ANOTHER RESTENOSIS AT THE AREA OF THE STENT FRACTURE. THIS CASE IS 8TH OF 29 EVENTS. THE PATIENT WAS A (B)(6) FEMALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS LEFT ANTERIOR DESCENDING (LAD), BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NEITHER AN IN-STENT RESTENOSIS NOR A CHRONIC TOTAL OCCLUSION. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, THREE CYPHER BX (SIZE AND LOT UNKNOWN) WERE IMPLANTED. THE TOTAL STENT LENGTH WAS 56MM AND THE DIAMETER OF THE STENT WAS 3.0MM; HOWEVER, THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. AT THE FIRST FOLLOW-UP ANGIOGRAPHY SIX TO NINE MONTHS AFTER STENT IMPLANTATION, THE STENT WAS NOTED TO BE FRACTURED AND DISPLACED WITH 56% RESTENOSIS. THE PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY INITIALLY, BUT LATER HAD THE IMPLANTATION OF A PACLITAXEL-ELUTING STENT DUE TO FURTHER RESTENOSIS. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. MULTIPLE ATTEMPTS TO DETERMINE WHICH OF THE THREE CYPHER STENTS WAS FRACTURED WERE UNSUCCESSFUL. IT IS OUR INTENTION TO REPORT CONSERVATIVELY WHEN INFORMATION IS NOT AVAILABLE AND THEREFORE ALL THREE CYPHER STENTS WILL BE REPORTED WITH FRACTURE AND RESTENOSIS. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. STENT DAMAGE/DEFORMATION AND RESTENOSIS/REOCLUSSION ARE KNOWN ADVERSE EVENTS INDICATED IN THE IFU. WHILE NOT OBSERVED IN THE PIVOTAL 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. BASED ON THE LIMITED PROCEDURAL INFORMATION AND WITHOUT FILMS, IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING THE REPORTED EVENTS. HOWEVER, VESSEL/LESION CHARACTERISTICS AND PROCEDURAL FACTORS ARE LIKELY CONTRIBUTING FACTORS. THERE IS NO INDICATION THAT THE EVENTS ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00938, 9616099-2010-00939 AND 9616099-2010-00940. SINCE ONLY ONE OF THE THREE IMPLANTED STENTS FRACTURED, TWO OF THE REPORTS NO LONGER MEET FDA REPORTABILITY CRITERIA AND WERE UNREPORTED. THIS IS THE ONLY REPORT THAT WAS ASSOCIATED WITH A REPORTABLE EVENT. (B)(4) CYPHER PRODUCT (CJS) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS).

    Description of Event or Problem · 1

    AS REPORTED VIA THE AMERICAN HEART JOURNAL (2010;160:775.E1-775.E9) ARTICLE ENTITLED "SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION" A PATIENT EXPERIENCED A DISLOCATED STENT FRACTURE WITH RESTENOSIS 6-9 MONTHS AFTER STENT IMPLANTATION, AND LATER HAD ANOTHER RESTENOSIS AT THE AREA OF THE STENT FRACTURE. THIS CASE IS 8TH OF 29 EVENTS. THE PATIENT WAS A (B)(6) FEMALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS LEFT ANTERIOR DESCENDING (LAD), BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NEITHER AN IN-STENT RESTENOSIS NOR A CHRONIC TOTAL OCCLUSION. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, THREE CYPHER BX (SIZE AND LOT UNKNOWN) WERE IMPLANTED. THE TOTAL STENT LENGTH WAS 56MM AND THE DIAMETER OF THE STENT WAS 3.0MM; HOWEVER, THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. AT THE FIRST FOLLOW-UP ANGIOGRAPHY SIX TO NINE MONTHS AFTER STENT IMPLANTATION, THE STENT WAS NOTED TO BE FRACTURED AND DISPLACED WITH 56% RESTENOSIS. THE PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY INITIALLY, BUT LATER HAD THE IMPLANTATION OF A PACLITAXEL-ELUTING STENT DUE TO FURTHER RESTENOSIS.

    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 54 YR Hospitalization| R