BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1973942 · Received January 31, 2011

    Report

    Report Number
    3003742446-2011-00047
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    July 19, 2010
    Report Date
    January 6, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT POST CYPHER STENT IMPLANTATION THIS (B)(4) STUDY PATIENT EXPERIENCED CORONARY RESTENOSIS, ANGINA, FATIGUE AND SHORTNESS OF BREATH. THE PATIENT UNDERWENT THE INDEX PROCEDURE, FOR STABLE ANGINA, WITH DEPLOYMENT ONE CYPHER DRUG ELUTING STENT TO THE FIRST DIAGONAL. PAST MEDICAL HISTORY INCLUDED ATRIAL FIBRILLATION WITH ABLATION THERAPY, PREVIOUS MI, HYPERTENSION, HYPERCHOLESTEROLEMIA, FAMILY HISTORY OF CAD, GASTRIC BYPASS SURGERY, ANEMIA, CHOLECYSTECTOMY, GASTRIC REFLUX AND LASER CORRECTION SURGERY, AND ALLERGY TO SULFA (NAUSEA AND VOMITING). DURING THE INITIAL PROCEDURE, THE INDICATION FOR INTERVENTION WAS ANGINA PECTORIS. THE 1ST DIAGONAL HAD PRE-PROCEDURE STENOSIS OF 95% AND TIMI FLOW OF 2. THERE WAS PARTIAL FLOW/PERFUSION. THE LESION LENGTH WAS 12MM AND THERE WAS NO CALCIFICATION. THE LESION WAS INITIALLY PRE-DILATED WITH A 2.25MM APEX BALLOON AT 8 ATMS, FOLLOWED BY 2.5MM VOYAGER BALLOON ALSO AT 8 ATM. A 2.25X13MM CYPHER STENT WAS DEPLOYED AT 11 ATM. POST-DILATATION WAS PERFORMED WITH THE SDS AT 12 ATM. POST-DILATATION WAS PERFORMED WITH A 2.25MM DURASTAR BALLOON AT 14 ATM. POST PROCEDURAL RESIDUAL STENOSIS WAS 10% WITH TIMI III FLOW. THE PATIENT WAS MAINTAINED ON AN ASA AND PLAVIX REGIMEN. THREE MONTHS LATER, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO CHEST PAIN AND SEVERE FATIGUE. AN MI WAS RULED OUT BUT THE PATIENT CONTINUED TO EXPERIENCE CHEST PAIN. SHE WAS REFERRED FOR A CARDIAC CATHETERIZATION WHICH SHOWED CRITICAL LAD DISEASE AND SURGERY WAS RECOMMENDED. THE PATIENT RECEIVED A 2 VESSEL CABG REVASCULARIZATION LIMA-LAD/DIAG BR. FOR THE NEW GRAFT TO THE LAD THE CONDUIT WAS A LIMA. THE DIAMETER OF THE TARGET VESSEL WAS 3.5MM. FOR THE NEW GRAFT TO THE DIAGONAL THE CONDUIT WAS A LIMA. THE DIAMETER OF THE TARGET VESSEL WAS 2.5 MM. FOR BOTH, THE GRAFT TYPE WAS A BRIDGE AND THE RUN OFF WAS EXCELLENT. THERE WAS 90% STENOSIS OF THE LAD AND ALSO OF THE DIAGONAL. HOWEVER, THE DIAGONAL STENT WAS PATENT. OVERALL PREOPERATIVE LEFT VENTRICULAR FUNCTION/EJECTION FRACTION AS 55%. POST-OPERATIVELY, THE PATIENT HAD AN ARRHYTHMIA CONSULT FOR RECOMMENDATIONS ON THE TREATMENT OF ATRIAL FIBRILLATION GIVEN HER HISTORY OF PANCREATITIS. SHE HAD ELEVATED LFTS AND NAUSEA AT THE TIME AND WAS RECOMMENDED DIGOXIN AND LOPRESSOR. THE PATIENT ALSO HAD A PULMONARY CONSULT DUE TO SHORTNESS OF BREATH AND LEFT PLEURAL EFFUSION. SHE HAD LEFT THORACENTESIS AND AGAIN 3 DAYS LATER. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON 9 DAYS AFTER THE SURGERY. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15121668 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. IN-STENT RESTENOSIS, ASSOCIATED WITH THE SYMPTOMS OF ANGINA, FATIGUE AND SHORTNESS OF BREATH, IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE IN-STENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. IN THIS CASE, THE IN-STENT RESTENOSIS WAS CAPTURED DUE TO THE PROXIMITY OF PROGRESSIVE DISEASE IN THE NATIVE ARTERY ADJACENT TO THE IMPLANTED STENT. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, SPECIFICALLY THE RISK FACTORS FOR ATHEROSCLEROTIC DISEASE; I.E. HYPERTENSION AND HYPERLIPIDEMIA.

    Additional Manufacturer Narrative · 1

    SHE HAD ELEVATED LFTS AND NAUSEA AT THE TIME AND WAS RECOMMENDED DIGOXIN AND LOPRESSOR. THE PATIENT ALSO HAD A PULMONARY CONSULT DUE TO SHORTNESS OF BREATH AND LEFT PLEURAL EFFUSION. SHE HAD LEFT THORACENTESIS AND AGAIN 3 DAYS LATER. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 9 DAYS AFTER THE SURGERY. DURING THE INITIAL PROCEDURE, THE INDICATION FOR INTERVENTION WAS ANGINA PECTORIS AND THE PATIENT WAS DIAGNOSED WITH AN MI. THE 1ST DIAGONAL HAD PRE-PROCEDURE STENOSIS OF 95% AND TIMI FLOW OF 2. THERE WAS PARTIAL FLOW/PERFUSION. THE LESION LENGTH WAS 12MM AND THERE WAS NO CALCIFICATION. THE LESION WAS INITIALLY PRE-DILATED WITH A 2.25MM APEX BALLOON AT 8 ATM, FOLLOWED BY 2.5MM VOYAGER BALLOON ALSO AT 8 ATM. A 2.25X13MM CYPHER STENT WAS DEPLOYED AT 11 ATM. POST-DILATATION WAS PERFORMED WITH THE SDS AT 12 ATM. POST-DILATATION WAS PERFORMED WITH A 2.25MM DURASTAR BALLOON AT 14 ATM. CONCOMITANT DEVICES ((B)(6) 2010): .038 J WIRE, 5 F FL4, 5F PIGTAIL, 6F SHEATH, 6F GL 3.5 GUIDING CATHETER, .014IN BMW-HC GUIDEWIRE, 2.25MM APEX BALLOON, 2.5MM VOYAGER BALLOON, 2.25X13MM DURASTAR BALLOON, PERCLOSE ARTERIAL CLOSURE DEVICE, CONTRAST, OMNIPAQUE 350CC. CONCOMITANT MEDICATIONS ((B)(6) 2010): INTRA-PROCEDURE: HEPARIN AND NITROGLYCERIN. ASPIRIN WAS GIVEN PRE AND POST-PROCEDURE. CLOPIDOGREL WAS GIVEN POST-PROCEDURE. CONCOMITANT MEDICATIONS: PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, ADP INHIBITORS AND STATIN. POST-PROCEDURE MEDICATIONS INCLUDED AMIODARONE, ZANTAC, PLAVIX, LAXATIVE OF CHOICE, LISINOPRIL, TOPROL XL, ENTERIC COATED ASPIRIN, BIOTIN, CALCIUM CITRATE, ZYRTEC, CYANOCABALAMIN, VITAMIN D, LEXAPRO, FIBER CAPS, FLUTICASONE INHALER, MVI 3 AND K-DUR. THIS PRODUCT IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY THAT DUE TO STABLE ANGINA, THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH DEPLOYMENT ONE DRUG ELUTING STENT TO THE FIRST DIAGONAL. POST PROCEDURAL RESIDUAL STENOSIS WAS 10% WITH TIMI III FLOW. THREE MONTHS LATER, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO CHEST PAIN AND SEVERE FATIGUE. AN MI WAS RULED OUT AFTER DISCHARGE BUT THE PATIENT CONTINUED TO EXPERIENCE CHEST PAIN. SHE WAS REFERRED FOR A CARDIAC CATHETERIZATION WHICH SHOWED CRITICAL LAD DISEASE AND SURGERY WAS RECOMMENDED. THE PATIENT RECEIVED A 2 VESSEL CABG REVASCULARIZATION LIMA-LAD/DIAG BR. FOR THE NEW GRAFT TO THE LAD THE CONDUIT WAS A LIMA. THE DIAMETER OF THE TARGET VESSEL WAS 3.5MM. FOR THE NEW GRAFT TO THE DIAGONAL THE CONDUIT WAS A LIMA. THE DIAMETER OF THE TARGET VESSEL WAS 2.5 MM. FOR BOTH, THE GRAFT TYPE WAS A BRIDGE AND THE RUN OFF WAS EXCELLENT. THERE WAS 90% STENOSIS OF THE LAD AND ALSO OF THE DIAGONAL. HOWEVER, THE DIAGONAL STENT WAS PATENT. OVERALL PREOPERATIVE LEFT VENTRICULAR FUNCTION/EJECTION FRACTION AS 55%. POST-OPERATIVELY THE PATIENT HAD AN ARRHYTHMIA CONSULT FOR RECOMMENDATIONS ON THE TREATMENT OF ATRIAL FIBRILLATION GIVEN HER HISTORY OF PANCREATITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15121668

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R