BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021009 · Received March 26, 2008

    Report

    Report Number
    9616099-2008-00792
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    September 24, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CYPHER SELECT PRODUCT IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT. 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: 9616099-2008-00792, 9616099-2008-00793, AND 9616099-2008-00794.

    Description of Event or Problem · 1

    THIS PT IS A FEMALE, AND HAS A BMI OF 28.44. SHE HAS AN ALLERGY TO ZOROXID AND A PMH OF PREVIOUS PCI WITH REVASCULARIZATION AND STENTING IN 2006, HTN, HYPERLIPIDEMIA, SMOKING, MI, PVD, GASTRO DUODENAL ULCER, AND A FAMILY HISTORY OF CAD. SHE WAS ON A DAILY MEDICATION REGIMEN OF PLAVIX, STATINS, ACE INHIBITORS, AND BETA-BLOCKERS. IN 2007, THIS PT PRESENTED WITH STABLE ANGINA AND BASELINE DATA GATHERED REVEALED SR-SB 55, BP210/80, EF OF >50%, LABS - CREATININE=0.85, PLATELET COUNT OF 201, AND HG. OF 14.0. THE FOLLOWING DAY, THE PT WAS TAKEN TO THE CVL AND STARTED ON A HEPARIN GTT FOR PCI. ANGIOGRAPHY REVEALED TRIPLE VESSEL DISEASE TO INCLUDE A RE-STENOTIC LESION OF THE MLAD WITH INSTENT RESTENOSIS OF UNK STENT. THIS B2 RESTONOTIC, CONCENTRIC, NON-OSTIAL WITH BIFURCATION LESION MEASURED 2.75MM X 24MM WITH 70% STENOSIS IN WHICH THERE IS >10MM OF THE 24MM THAT IS DIFFUSE IN-STENT RESTENOSIS. A 6FR GUIDING CATHETER WAS PLACED AND A 2MM X 20MM BALLOON WAS INTRODUCED AND PRE DILATED LESION AT 10 ATM'S PRESSURE. A 2.75MM X 28MM CYPHER SELECT PLUS STENT WAS INTRODUCED AND OVERLAPPED EXISTING STENTS AND DEPLOYED AT 16 ATM'S WITH GOOD RESULTS AND NO POST DILATATION REQUIRED. THE SECOND LESION TREATED WITH THIS PROCEDURE WAS THE DLAD WHICH WAS A B2 RESTENOTIC LESION WITH PROLIFERATIVE RESTENOSIS OF 90% AND MEASURED 2.50MM X 50MM. WITH THE 6FR GC, A 2MM X 20MM BALLOON WAS INTRODUCED TO PRE DILATE THIS LESION USING 10 ATM'S PRESSURE. A 2.5MM X 33MM CYPHER SELECT PLUS STENT WAS DEPLOYED OVERLAPPING OLD STENT AT 14 ATM'S PRESSURE. POST DILATION WAS DONE USING A 2.5MM X 23MM BALLOON AT 20 ATM'S. ANOTHER CYPHER SELECT PLUS STENT (2.5MM X 23MM, CRB23250, LOT# I0107042, EXP. 6/07) WAS INTRODUCED AND OVERLAPPED PREVIOUS STENT AND DEPLOYED USING 22 ATM'S PRESSURE WITH GOOD RESULTS. NO POST DILATION WAS REQUIRED. THAT SAME DAY POST PCI, THIS PT DEVELOPED MILD RETROSTERNAL PAIN AND WAS GIVEN CEDACARD. CARDIAC ENZYMES WERE DRAWN AND BOTH THE TROPONIN, AND THE CK-MB WERE POSITIVE. TROPONIN >/= 5X'S ABOVE UNI, AND MB <2X'S ABOVE UNI. EKG WAS UNCHANGED, AND PAIN SUBSIDED. PT WAS DISCHARGED HOME THE NEXT DAY ON A DAILY MEDICATION REGIMEN OF ASPIRIN (ASA), PLAVIX, ACE INHIBITORS, AND BETA-BLOCKERS. ONE MONTH LATER, PT HAD CONTINUOUS MILD ANGINA. NO TREATMENT AT THAT TIME, BUT PT WAS TAKEN OFF THE ASA DUE TO AN ALLERGY, AND IT IS NOTED THAT PT IS ONLY TAKING PLAVIX AND OTHER LIPID LOWERING MEDICATIONS. ACE INHIBITORS AND BETA-BLOCKERS HAVE ALSO BEEN DISCONTINUED. FIVE MONTHS AFTER THE PT'S 1-MONTH F/U VISIT, THE PT HAD AN UNSCHEDULED VISIT TO THE HOSPITAL FOR PERSISTENT ATRIAL FIBRILLATION AND ARRHYTHMIA PROBLEMS. EKG WAS PERFORMED AS WELL AS AN ANGIOGRAPHY WHICH REVEALED 60% IN-STENT RESTENOSIS OF BOTH THE MID, AND THE PROXIMAL LAD. NO REVASCULARIZATION WAS DONE AT THIS TIME. PT WAS SENT HOME AND RESTARTED ON BETA-BLOCKERS AND ACE INHIBITORS AND CONTINUED WITH THE PLAVIX AND STATINS. TEN DAYS AFTER THE PT LEFT THE HOSPITAL, SHE WAS CONTACTED FOR HER 6 MONTH F/U VISIT AND STILL HAD PERSISTENT ANGINA. PT IS COMPLIANT WITH HER MEDICATION REGIMEN. TWELVE DAYS AFTER F/U VISIT, PT WAS HOSPITALIZED AGAIN FOR ANGINA AND STAGED PROCEDURE/REPCI FOR THE 60% IN-STENT RESTENOSIS OF THE MID, AND PROXIMAL LAD. BOTH LESIONS WERE TREATED WITH BALLOON DILATION ONLY WITH UNK SPECIFICS. THE PT RETURNED TO THE HOSPITAL 2 MONTHS LATER WITH RECURRENT ANGINA. PT WAS COMPLIANT WITH HER MEDICATION REGIMEN OF PLAVIX, STATINS, AND BETA-BLOCKERS. PT WAS SCHEDULED FOR CABG AND CRYOABLATION. IN 2008, THIS PT WAS ADMITTED TO ANOTHER HOSPITAL TO HAVE CABG X 3. RIMA-LAD, LIMA-CX, AND SVG TO DISTAL RCA. FOR THE ARRHYTHMIA PROBLEM, A CRYOABLATION WAS PERFORMED. DURING THIS HOSPITALIZATION, THE PT DEVELOPED THE FOLLOWING POST-OP COMPLICATIONS. SVT RHYTHM DISTURBANCES, SHE NEEDED A PLEURAL PUNCTURE, AND HAD A PACEMAKER IMPLANTED 10 DAYS POST OP D/T DDD PACEMAKER DEPENDENCY POST-OP. PT ALSO DEVELOPED A UTI AND WAS TREATED WITH CIPROXINE. PT WAS DISCHARGED NINETEEN DAYS AFTER ADMISSION. AT PT'S ONE-YEAR F/U VISIT, SHE WAS ASYMPTOMATIC AND COMPLIANT WITH HER MEDICATION AND REHABILITATION REGIMEN.

    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 I1106134

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R PLAVIX