BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1082457 · Received July 25, 2008

    Report

    Report Number
    9616099-2008-01855
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 30, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT IS RELATED TO A MFG ISSUE OR DEVICE DEFECT. THERE ARE PT, VESSEL, LESION, AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS REPORTED THROMBOTIC EVENT. CYPHER SELECT PRODUCT IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT.

    Description of Event or Problem · 1

    THE STUDY INDICATES THAT IN 2008, THE PT SUFFERED A STENT THROMBOSIS AND A MYOCARDIAL INFARCTION, AND ON THE NEXT DAY, THE PT UNDERWENT A RE-PCI. THIS FEMALE PT WITH A HISTORY OF PREVIOUS MI WITH PCI AND STENTING OF THE CIRCUMFLEX ARTERY (LCX) IN DEC. 2006 (3.0 X 12MM TECNIC STENT), HYPERTENSION, HIGH CHOLESTEROL, INSULIN-DEPENDANT DIABETES, AND KNOWN PERIPHERAL VASCULAR DISEASE WAS ADMITTED FOR CORONARY INTERVENTION. SHE WAS CURRENTLY TAKING ASPIRIN, PLAVIX, STATINS, ACE INHIBITORS, AND BETA-BLOCKERS. THE INDICATION FOR THE PROCEDURE WAS SILENT ISCHEMIA AS EVIDENCE ON NUCLEAR STRESS TEST. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE; CLOTTING TIMES WERE NOT MONITORED. BASELINE VITAL SIGNS AND LABS REVEALED SYSTOLIC HYPERTENSION (184/51 MMHG) AND ANEMIA (HGB 10.2 G/DL. ANGIOGRAPHY REVEALED A 70%, 13MM IN-STENT RESTENOSIS OF THE PREVIOUSLY PLACED TECHNIC STENT IN THE MID-LCX. THE LESION WAS IRREGULAR, ECCENTRIC AND MODERATELY CALCIFIED. THE VESSEL WAS 3.0MM IN DIAMETER. THE SITE WAS NOT PRE-DILATED. A 3.0 X 13MM CYPHER SELECT STENT WAS DEPLOYED TO 16 ATMS WITH GOOD RESULTS. THERE WERE NO COMPLICATIONS REPORTED AND THE PT WAS DISCHARGED THE FOLLOWING DAY IN STABLE CONDITION. APPROX 11 MONTHS POST PROCEDURE, THE PT EXPERIENCED A TARGET-VESSEL RELATED, NON Q-WAVE MI. TROPONIN WAS ELEVATED >5 TIMES ULN. THE PT WAS STILL TAKING ASPIRIN, AND PLAVIX AS PRESCRIBED. ANGIOGRAPHY REVEALED A THROMBUS WITHIN THE CYPHER STENT IN THE MID-LCX. THE THROMBUS RESULTED IN A 60% BLOCKAGE OF THE VESSEL; HOWEVER, FLOW BEYOND THE BLOCKAGE WAS TIMI III. THE THROMBOSIS WAS SUCCESSFULLY TREATED WITH BALLOON ANGIOPLASTY AND THE EVENT RESOLVE WITHOUT SEQUELAE. THE PRODUCT(S) ARE NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MFG ROUTE SHEETS FOR THE INVOLVE LOT(S) CONFIRMED THAT THE DEVICE(S) MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. IN-STENT THROMBOSIS IS A KNOWN POTENTIAL OUTCOME OF CORONARY STENTING AND IS MULTI-FACTORIAL IN ETIOLOGY. SUBSEQUENT STENT BLOCKAGE MAY REQUIRE REPEAT DILATION OF THE STENTED AREA. WELL-KNOWN PREDICTORS ASSOCIATED WITH A HIGHER RATE OF THROMBOTIC EVENTS FOLLOWING STENT IMPLANTATION INCLUDE PHARMACOLOGICAL FACTOR SUCH AS DISCONTINUATION OF ANTIPLATELET THERAPY; ANGIOGRAPHIC FACTORS SUCH AS LONG LESIONS, MULTIPLE STENTS, CALCIFIED LESIONS AND SMALL VESSELS; PT-RELATED FACTORS SUCH AS ACUTE PRESENTATION, SMOKING AND CONGESTIVE HEART FAILURE; AND PROCEDURAL FACTORS SUCH AS INADEQUATE POST-PROCEDURE LUMEN DIMENSIONS, DISSECTION, THROMBUS, AND TISSUE PROLAPSE. IN ADDITION, BIOLOGIC FACTORS, INCLUDING FAILED BRACHYTHERAPY, CHRONIC TOTAL OCCLUSIONS, PRIOR MYOCARDIAL INFARCTION AND PT AGE, MAY PLAY A ROLE INTHROMBOTIC EVENTS. IN THIS CASE, THE PT HAS A HISTORY OF PREVIOUS MI WITH PCI AND STENTING OF THE CIRCUMFLEX ARTERY (LCX) IN LATE 2006 (3.0 X 12MM TECNIC STENT), HYPERTENSION, HIGH CHOLESTEROL, INSULIN-DEPENDANT DIABETES, AND KNOWN PERIPHERAL VASCULAR DISEASE, WHICH MAY INCREASE HER RISK OF A MAJOR CARDIAC ADVERSE EVENT. THE LESION WAS A RESTENOSIS WITHIN A PREVIOUSLY PLACED STENT AND WAS IRREGULAR, CALCIFIED, AND ECCENTRIC. THE LESION WAS 13MM LONG AND THE STENT WAS 13MM LONG, WHICH MAY IMPLY THAT THE STENT DID NOT COVER FROM HEALTHY TISSUE TO HEALTHY TISSUE.

    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 13211437

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R STATINS| BETA BLOCKERS| PLAVIX| ASPIRIN| ACE INHIBITORS