BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1063218 · Received June 17, 2008

    Report

    Report Number
    9616099-2008-01528
    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

    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 PT 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 2.67 MM 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 14ATM. INFLATION TIME WAS UNK. 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. APPROX. SIX MONTHS LATER, THE PT CAME TO THE HOSPITAL BECAUSE HE COMPLAINED OF CHEST PAIN DURING WALKING. ONE WEEK LATER, THE PT 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 PT WAS BEING TREATED WITH INTERNAL MEDICINE AND HIS CONDITION WAS BEING FOLLOWED. TWO YEARS AND NINE-MONTHS POST INDEX PROCEDURE, THE PT COMPLAINED OF CHEST PAIN AND, SO ANGIOGRAPHY WAS AGAIN CONDUCTED. THERE WERE 50% STENOSES IN THE PROXIMAL THROUGH DISTAL RCA, PROXIMAL LAD (CYPHER IN-STENT RESTENOSIS), SECOND DIAGONAL BRANCH AND PROXIMAL THRU MID LCX. ADDITIONALLY, THERE WERE 90% STENOSES IN THE PDA AND THE DISTAL LCX, 75% STENOSES 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 WAS REPORTED. THREE YEARS POST INDEX PROCEDURE, THE PT WAS AGAIN HOSPITALIZED. ANGIOGRAPHY REVEALED A 60.09% RESTENOSIS FROM THE DISTAL END OF THE 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 8ATM 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 % OF 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 PT 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 PT EASILY CAN GET CARDIO STENOSIS. ANTI-PLATELET THERAPY CONDUCTED IS FOLLOWING: HEPARIN 10,000/DAY: 2005-APR-5. ISOSORBIDE DINITRATE 40 MG/DAY: 2003~. WARFARIN POTASSIUM: 3MG/DAY: 2005, CARVEDILOL 10MG/DAY: 2003. AMLODIPINE BESILATE 10MG/DAY: 2005. NITROGLYCERIN 0.3MG/DAY: 2005 (WHEN CHEST PAIN OCCURRED). NITROGLYCERIN 45ML/DAY: 2005. THE PRODUCT(S) ARE NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING ROUTE SHEETS FOR THE INVOLVED LOT(S) CONFIRMED THAT THE DEVICE(S) MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. IN-STENT RESTENOSIS IS A KNOWN POTENTIAL OUTCOME OF CORONARY STENTING AND IS MULTI-FACTORIAL IN ETIOLOGY. SUBSEQUENT STENT BLOCKAGE MAY REQUIRE REPEAT DILATION OF THE STENTED ARE. WELL-KNOWN PREDICTORS ASSOCIATED WITH A HIGHER RATE OF RESTENOSIS FOLLOWING STENT IMPLANTATION INCLUDE PT FACTORS SUCH AS SEX, PRIOR HISTORY OF RESTENOSIS, DIABETES, HYPERLIPIDEMIA, HYPERTENSION, UNSTABLE ANGINA, VASOSPASTIC ANGINA, RENAL DISEASE, AND SMOKING; PROCEDURAL FACTORS SUCH AS DEVICE-TO-ARTERY RATIO, PRESENCE OF SIGNIFICANT RESIDUAL GRADIENT, SIGNIFICANT RESIDUAL STENOSIS, AND THE EXTENT OF DISSECTION; AND ANGIOGRAPHIC FACTORS SUCH AS THE SIZE OF THE REFERENCE VESSEL, SEVERITY OF STENOSIS, PRESENCE OF CALCIUM, ECCENTRIC LESIONS, SAPHENOUS VEIN GRAFT LOCATION, OSTIAL OR PROXIMAL LESION LOCATION, AND LEFT ANTERIOR DESCENDING LESION LOCATION, AS WELL AS CHRONIC TOTAL OCCLUSION AND LONG LESIONS. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT IS RELATED TO A MANUFACTURING ISSUE OR DEVICE DEFECT. THERE ARE MULTIPLE PT, VESSEL, LESION, PROCEDURAL, AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS REPORTED EVENT OF RESTENOSIS.

    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 I0205074

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R