BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1023347 · Received April 1, 2008

    Report

    Report Number
    9616099-2008-00835
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    April 16, 2007
    Report Date
    March 4, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF THREE REPORTS SUBMITTED FOR RELATED EVENTS OCCURRING IN THE SAME PT. PLEASE REFERENCE MFR REPORT #S: 9616099-2008-00826, 9616099-2008-00835, AND 9616099-2008-00836.

    Description of Event or Problem · 1

    A MALE PT WITH A HISTORY OF PREVIOUS MI, PREVIOUS PCI WITH CYPHER STENT (TARGET LESION, 2005), PREVIOUS CORONARY BYPASS SURGERY (CABG, 1988), HYPERTENSION, HYPERLIPIDEMIA, SMOKING, IODINE ALLERGY, INSULIN-DEPENDANT DIABETES, AND MODERATE TO SEVERE RENAL DISEASE WAS ADMITTED FOR CORONARY EVALUATION. HE WAS CURRENTLY TAKING ASPIRIN, PLAVIX, AND ACE INHIBITORS. THE PRIMARY INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA. BASELINE LAB AND VITAL SIGNS REVEALED SYSTOLIC HYPERTENSION (171/57 MMHG). ANGIOGRAPHY REVEALED A 90%, 15MM, DE NOVO, IRREGULAR, ECCENTRIC, TYPE-C LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AND A 50%, 33MM, IRREGULAR, ECCENTRIC TYPE-C IN-STENT RESTENOSIS OF A PREVIOUSLY PLACE CYPHER STENT (2005). REOPRO WAS ADMINISTERED. CLOTTING TIMES WERE NOT MEASURED. THE MID-LAD WAS PREDILATED WITH A 2.0 X 9MM BALLOON INFLATED TO 8 ATMS. A 2.5 X 18MM CYPHER SELECT PLUS STENT WAS DEPLOYED TO 12 ATMS WITH SATISFACTORY RESULTS. THE STENT WAS POST DILATED WITH A 2.5 X 18MM BALLOON INFLATED TO 18 ATMS. RESIDUAL STENOSIS WAS 0%. THE IN-STENT RESTENOSIS IN THE PROXIMAL LAD WAS NOT PREDILATED. A 2.75 X 33MM CYPHER SELECT STENT WAS POSITIONED TO COVER THE LESION AND WAS DEPLOYED TO 16 ATMS. THERE WAS A 2MM GAP BETWEEN THE STENTS IN THE PROXIMAL AND MID LAD. THE STENT WAS POST DILATED WITH A 2.75 X 33MM BALLOON INFLATED TO 18 ATMS. RESIDUAL STENOSIS WAS 0%. POST PROCEDURE, THE PT'S CARDIAC ENZYMES WERE ELEVATED (CK = 2 TIMES ULN, CK-MB =/> 5 TIMES ULN, AND TROPONIN =/> 5 TIMES ULN). THERE WERE NO ECG CHANGES NOTED. THE PT WAS RULED IN FOR A TARGET VESSEL RELATED MI, WHICH WAS ATTRIBUTED TO THE OCCLUSION OF SMALL SIDE BRANCHES DURING STENT IMPLANTATION. NO ADD'L TREATMENT WAS REQUIRED. APPROXIMATELY 6 MONTHS POST INDEX PROCEDURE, THE PT PRESENTED WITH ACUTE CORONARY SYNDROME (ACS) WITH ACUTE PULMONARY EDEMA (KILLIP CLASS III). CARDIAC ENZYMES WERE ELEVATED; HOWEVER, NO ECG CHANGES WERE NOTED. THE PT WAS REPORTED TO BE COMPLIANT WITH ALL CARDIAC MEDICATIONS. THE PT WAS TAKEN FOR RE-ANGIOGRAPHY TWO DAYS LATER. THIS REVEALED AN 85% IN-STENT RESTENOSIS OF THE 2.5 X 18 MM CYPHER SELECT PLUS STENT IN THE MID-LAD. THERE WAS 0% RESTENOSIS IN THE CYPHER SELECT PLUS STENT IN THE PROXIMAL LAD. THE RESTENOSIS WAS TREATED WITH THE PLACEMENT OF AN ADDITIONAL 2.25 X 33MM CYPHER SELECT PLUS STENT IN THE MID-LAD. NO PROCEDURAL COMPLICATIONS WERE NOTED. THE PT WAS DISCHARGED AFTER ONE WEEK.

    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 13183733

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR PLAVIX| ASPIRIN| 2.5 X 18MM CYPHER SELECT STENT| 2.75 X 33MM BALLOON| REOPRO| 2.5 X 18MM BALLOON| 2.0 X 9MM BALLOON