BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1063217 · Received June 17, 2008

    Report

    Report Number
    9616099-2008-01529
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    January 21, 2008
    Report Date
    May 19, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS CYPHER PRODUCT IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT. THIS IS ONE OF TWO REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR. REPORT #S: 9616099-2008-01528 AND 9616099-2008-01529.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM THE REGISTRY: THIS PATIENT HAS A PREVIOUS MEDICAL HISTORY OF MI, HYPERTROPHIC CARDIOMYOPATHY, PREVIOUS PCI, HYPERTENSION, LIPID METABOLISM ABNORMALITY, DIABETES, CHRONIC NEPHRITIS AND HYPERURICEMIA. HE WAS ADMITTED FOR UNSTABLE ANGINA. ANGIOGRAPHY REVEALED A DE NOVO, ECCENTRIC, BIFURCATED AND DIFFUSED LESION IN THE PROXIMAL LAD. THE VESSEL WAS MODERATELY CALCIFIED AND MODERATELY FLEXED. THE DIAMETER OF THE VESSEL WAS 2.67MM AND THE LESION LENGTH WAS 34.42 MM. PRE-PROCEDURE STENOSIS WAS 61.8%. AHA/ACC CLASSIFICATION OF THE VESSEL WAS A TYPE C. IT WAS AN ELECTIVE CASE. THE FEMORAL APPROACH WAS CHOSEN FOR THE PROCEDURE. PRE-DILATION WAS CONDUCTED WITH A BALLOON (2.5/15MM) AT 14 ATM. INFLATION TIME WAS UNKNOWN. ROTABLATOR WAS CONDUCTED. A CYPHER (3.0/28MM) WAS IMPLANTED AT 14 ATM FOR 16-30 SECONDS. THEN A 2ND CYPHER (3.0/33MM) WAS IMPLANTED AT 16 ATM FOR 16-30 SECONDS, PROXIMAL TO THE 1ST CYPHER WITH OVERLAP. POST-DILATION WAS CONDUCTED WITH A BALLOON (2.5/15MM) FOR 14 ATM. TIMI FLOW BEFORE AND AFTER THE PROCEDURE WAS 3. THE RESIDUAL % OF STENOSIS WAS 9.3%. IVUS WAS CONDUCTED. THERE WAS NO PROBLEM REGARDING THIS IMPLANT AND THE PRODUCT. APPROXIMATELY SIX MONTHS LATER, THE PATIENT CAME TO THE HOSPITAL BECAUSE HE COMPLAINED OF CHEST PAIN DURING WALKING. ONE WEEK LATER, THE PATIENT UNDERWENT ANGIOGRAPHY, WHICH REVEALED A 21.2% STENOSIS OBSERVED AT IN THE PROXIMAL LAD, BUT THE STENT WAS PATENT. THERE WAS UNTREATED LESION IN THE PROXIMAL THROUGH DISTAL RCA, THE PROXIMAL THROUGH DISTAL LCX, AND THE MID LAD AT AHA1-3, 11, 13, 12 AND 7, BUT NO TREATMENT WAS CONDUCTED BECAUSE THESE LESIONS WERE UNDER 50% STENOSIS AND, SO THE PATIENT WAS BEING TREATED WITH INTERNAL MEDICINE AND HIS CONDITION WAS BEING FOLLOWED. TWO YEARS AND NINE-MONTHS POST INDEX PROCEDURE, THE PATIENT COMPLAINED OF CHEST PAIN AND SO ANGIOGRAPHY WAS AGAIN CONDUCTED. THERE WERE 50% STENOSIS IN THE PROXIMAL THROUGH DISTAL RCA, PROXIMAL LAD (CYPHER IN-STENT RESTENOSIS), SECOND DIAGONAL BRANCH AND PROXIMAL THRU MID LCX. ADDITIONALLY, THERE WERE 90% STENOSIS IN THE PDA AND THE DISTAL LCX, 75% STENOSIS IN THE ATRIOVENTRICULAR BRANCH, THE MID THROUGH DISTAL LAD AND THE POSTERIOR DESCENDING BRANCH (LEFT), AND A 99% STENOSIS IN THE DIAGONAL BRANCH. NO TREATMENT IS REPORTED. THREE YEARS POST INDEX PROCEDURE, THE PATIENT WAS AGAIN HOSPITALIZED. ANGIOGRAPHY REVEALED A 60.09% RESTENOSIS FROM THE DISTAL END OF 1ST CYPHER TOWARDS THE 2ND CYPHER IMPLANTED IN THE PROXIMAL LAD. TO TREAT THE RESTENOSIS, PRE-DILATION WAS CONDUCTED WITH A BALLOON (3.0/15MM) INFLATED TO 8 ATM AND THE RESIDUAL % OF STENOSIS WAS 41.66%. THEN TO TREAT A 51.46% STENOSIS THE MID-LCX, A CYPHER (3.0/23MM) WAS DEPLOYED TO 16 ATM AND THE RESIDUAL % STENOSIS WAS 11.40%. THEN BALLOON ANGIOPLASTY WAS CONDUCTED IN A 75.53% LESION IN THE DISTAL LCX. THE RESIDUAL % OF STENOSIS WAS 41.22%. THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION. PHYSICIAN'S COMMENT: THE PROBABLE CAUSE OF THIS EVENT MIGHT BE DUE TO THE FACT THAT THE PATIENT EASILY CAN GET CARDIO STENOSIS. ANTI-PLATELET THERAPY CONDUCTED IS FOLLOWING: HEPARIN 10,000U/DAY: 2005-APR-5; ISOSORBIDE DINITRATE 40 MG/DAY: 2003; ASPIRIN 81 MG/DAY: 2003; TICLOPIDINE HYDROCHLORIDE 200 MG/DAY: 2003; WARFARIN POTASSIUM 4.5 MG/DAY: 2003 ~ 2005; WARFARIN POTASSIUM 3 MG/DAY: 2005; CARVEDILOL 10 MG/DAY: 2003; AMLODIPINE BESILATE 10 MG/DAY: 2005; NITROGLYCERIN 0.3 MG/DAY: 2005 (WHEN CHEST PAIN OCCURRED); NITROGLYCERIN 45 ML/DAY: 2005.

    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 I0205085

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R