BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 897064 · Received August 10, 2007

    Report

    Report Number
    9616099-2007-01548
    Event Type
    Injury
    Date Received
    August 10, 2007
    Date of Event
    June 23, 2005
    Report Date
    October 23, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT ORIGINATED FROM THE STUDY. THE EVENT INVOLVES A PATIENT WITH A MEDICAL HISTORY INCLUDING PREVIOUS CORONARY ARTERY BYPASS GRAFT (CABG), HYPERTENSION, DIABETES, AND STABLE ANGINA (CCS2). THE PATIENT'S AGE, GENDER, AND MEDICAL HISTORY INCREASE HER RISKS FOR DEVELOPING MACE. THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION FOR AN UNKNOWN INDICATION. BASELINE CARDIAC ENZYMES INCLUDED CPK (230U/L), CK-MB (ND) AND TROPONIN (NEGATIVE). ANGIOGRAM REVEALED THREE VESSEL DISEASE INVOLVING: 90% STENOTIC LESION IN THE PROXIMAL CIRCUMFLEX (CX), 100% STENOSIS OF THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND 100% STENOSIS OF THE MID (RCA). AT INDEX, ONLY THE LESION AT THE PROXIMAL CIRCUMFLEX WAS TREATED WITH PRE-DILATION BEFORE IMPLANTATION OF A CYPHER (2.50X18) DEPLOYED AT 14 ATMS WITH RESULTING TIMI FLOW OF THREE. ANTIPLATELET THERAPY INCLUDED ASA, CLOPIDOGREL, HEPARIN, IIB-IIIA ANTAGONIST. THE USE OF IVUS OR MONITORING OF ACT'S WAS NOT INDICATED. BASELINE MEDICATIONS INCLUDED INSULIN, BETA-BLOCKERS, AND ACE INHIBITORS. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORT OF PATIENT INJURY. SOMETIMES PORT-PROCEDURE; THERE WAS ELEVATION IN CARDIAC ENZYMES WITH NO OTHER CLINICAL INDICATORS REPORTED. CPK INCREASED TO (463U/I), CK-MB (18) AND TROPONIN (<0.10). THREE HOURS LATER: CPK (406), CPK-MB (24), AND TROPONIN (<0.10). TEN HOURS LATER CARDIAC MARKERS: CPK (335), CK-MB (19) AND TROPONIN (<0.10). BASED ON THE TOTAL CK INCREASE OF MORE THAN TWO TIMES UNL, THE CEC INDICATED THIS EVENT WOULD BE REPORTED AS A NON-Q WAVE ACUTE MYOCARDIAL INFARCTION (AMI). THERE WAS NO REPORT OF PATIENT SEQUELA REPORTED OUTCOME OF EVENT RESOLVED. APPROXIMATELY THIRTEEN MONTHS POST THE INDEX PROCEDURE, THE PATIENT UNDERWENT A RE-PCI INDICATED BY ANGINA. RESTENOSIS OF THE PREVIOUS TREATED LESION IN THE PROXIMAL CIRCUMFLEX WAS REVASCULARIZED USING PLAIN OLD BALLOON ANGIOPLASTY (POBA) AND CUTTING BALLOON. IN CONCLUSION, MYOCARDIAL INFARCTION AND RESTENOSIS ARE KNOWN POTENTIAL ADVERSE EVENTS POST CORONARY STENTING ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. BASED ON THE AVAILABLE INFORMATION, PATIENT AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS MANUFACTURING RELATED. THIS FILE HAS BEEN RE-ACCESS AS PER THE SIMILAR DEVICE REPORTABILITY CRITERIA IMPLEMENTED BY CORDIS CORPORATION ON 12/15/06. THE MDR DETERMINATION HAS CHANGED FROM NOT REPORTABLE TO A REPORTABLE EVENT, AS THE DEVICE IS CONSIDERED TO BE SIMILAR TO THE UNITED STATES PRODUCT CYPHER SIROLIMUS-ELUTING CORONARY STENT. PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE DESSERT CLINICAL STUDY INDICATING THAT THE PATIENT EXPERIENCED AN ACUTE NON Q WAVE MYOCARDIAL INFARCTION PERI-CARDIAC INTERVENTION INVOLVING IMPLANTATION OF A CYPHER STENT. APPROXIMATELY THIRTEEN MONTHS LATER, THE PATIENT EXPERIENCED RESTENOSIS. THIS IS AN INITIAL AND FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS DE MEXICO NA R0204727

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R