BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1972467 · Received January 28, 2011

    Report

    Report Number
    3003742446-2011-00042
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    November 24, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BOTH THE PRASUGREL AND ASPIRIN MEDICATIONS WERE STOPPED ON (B)(6) 2010 AND THEN RESTARTED ON (B)(6) 2010. THE PRODUCT REMAINS IMPLANTED AND IS THEREFORE NOT AVAILABLE FOR EVALUATION. 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 15140118 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. THIS IS ONE OF TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURER REPORT NUMBERS 3003742446-2011-00041 AND 3003742446-2011-00042.

    Additional Manufacturer Narrative · 1

    WHITE COUNT 14, HEMOGLOBIN 8.4, PLATELET COUNT 218. PRIOR BUN AND CREATININE 24 AND 1.2 ON (B)(6) 2010. CHEST X-RAY REVIEWED ON PACS IMAGING BY THIS EXAMINER. BILATERAL INCREASED LUNG MARKINGS, LOW LUNG VOLUME, SWAN-GANZ IN PLACE. ECHOCARDIOGRAM (B)(6) 2010 SHOWS AN EJECTION FRACTION OF 33% TO 55% (THIS NEEDS CONFIRMING). HEMODYNAMICS SVR 938, CARDIAC INDEX 1.8. PULMONARY CAPILLARY WEDGE PRESSURE 24 WITH PA MEAN OF 32 AND CVP 18. LASIX 20MG, GLIPIZIDE 10MG, INSULIN ASPART, LISINOPRIL, LOVASTATIN 20MG, METFORMIN 1000MG, METROPOLOL 25MG, NYTROGLYCERIN 0.4 MG, POTASSIUM CHLORIDE 8MEQ, EFFIENT 10 MG, SALMON OIL 1000, ALDACTONE 25MG, MULTIVITAMIN AND VITAMIN B COMPLEX. THIS IS ONE OF TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 3003742446-2011-00041 AND 3003742446-2011-00042. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT DEVELOPED CORONARY ARTERY RESTENOSIS AND HEART FAILURE APPROXIMATELY FIVE MONTHS POST INDEX PROCEDURE. THIS IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING DIABETES MELLITUS, HYPERTENSION, A PREVIOUS PERCUTANEOUS CORONARY REVASCULARIZATION, AND A CORONARY ARTERY BYPASS GRAFT IN (B)(6) 2010. COPD (HAD QUIT SMOKING 20 YR AGO), CONGESTIVE HEART FAILURE, HEART MURMUR (AS A CHILD), IRREGULAR HEARTBEATS, LEG SWELLING, DIVERTICULITIS (HEMI-COLECTOMY), ARTHRITIS, MEASLES AND CHICKEN POX. THE PATIENT WAS ADMITTED TO THE INDEX PROCEDURE DUE TO UNSTABLE ANGINA AND UNDERWENT DEPLOYMENT OF A 3.0 X 13 CYPHER WAS DEPLOYED IN THE PROXIMAL CIRCUMFLEX. THERE IS MENTION OF A PREVIOUS STENT IN THE CIRCUMFLEX THAT IS PATENT. A 3.0 X 13MM CYPHER STENT WAS THEN DEPLOYED INTO A NEW AREA OF THE PROXIMAL LAD AT 20 ATMOSPHERES FOR 20 SECONDS. POST PROCEDURE RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. THE PATIENT WAS DISCHARGED FROM THE INDEX PROCEDURE HOSPITALIZATION THE FOLLOWING DAY. APPROXIMATELY FIVE MONTHS POST INDEX PROCEDURE; THE PATIENT WAS ADMITTED WITH HEART FAILURE AND DIAGNOSED WITH PROGRESSIVE CORONARY ARTERY DISEASE. THE PATIENT WAS ADMITTED WITH HEART FAILURE AND HAD A CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY AND VALVE SURGERY. TWO BYPASSES WERE PERFORMED. THE CABG OF THE SAPHENOUS VEIN GRAFT TO THE POSTERIOR DESCENDING ARTERY AND THE LEFT INTERNAL MAMMARY ARTERY TO THE LEFT ANTERIOR DESCENDING (LAD). TO DATE, NO FURTHER INFORMATION HAS BEEN AVAILABLE REGARDING THE PATENCY OF THE IMPLANTED CYPHER STENTS AND/OR THE PROXIMITY OF THE ADVANCING DISEASE TO THE IMPLANTED STENTS; HOWEVER, THE EVENT OF CORONARY ARTERY DISEASE PROGRESSION WILL BE CAPTURED AS A COMPLAINT. THE SURGERY WAS REPORTED TO HAVE BEEN COMPLETED WITH NO COMPLICATIONS AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION SIX DAYS LATER. IN THE OPINION OF THE INVESTIGATOR, THE PROGRESSION OF THE CORONARY ARTERY DISEASE WAS SEVERE IN INTENSITY, NOT RELATED TO THE STUDY DRUG, UNLIKELY RELATED TO THE STUDY DEVICE , AND NOT RELATED TO THE STUDY PROCEDURE. THE STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. 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 15140118 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. IN-STENT RESTENOSIS 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. HEART FAILURE, WHILE NOT SPECIFICALLY MENTIONED IN THE IFU, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE PROGRESSION OF CORONARY ARTERY DISEASE AND THE TREATMENT THERE OF. AS THE HEART MUSCLE BECOMES MORE ISCHEMIC FROM PROGRESSIVE ARTERY STENOSIS AND LACK OF BLOOD FLOW, THE MUSCLE BECOMES WEAKENED AND INEFFICIENT. THIS PROGRESSION LEADS TO THE PLETHORA OF HEART FAILURE SYMPTOMS, INCLUDING BUT NOT LIMITED TO CHEST PAIN, EDEMA, SHORTNESS OF BREATH AND EXERTION INTOLERANCE. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS, SPECIFICALLY THE RISK FACTORS FOR ATHEROSCLEROTIC DISEASE; I.E. HYPERTENSION, DIABETES AND PREVIOUS CONGESTIVE HEART FAILURE. THIS IS ONE OF TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURER REPORT NUMBERS 3003742446-2011-00041 AND 3003742446-2011-00042.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED FOR THE CABG SURGERY, THE PATIENT WAS ADMITTED WITH HEART FAILURE AND ALSO HAD VALVE SURGERY. TWO BYPASSES WERE PERFORMED. THE CABG OF THE SAPHENOUS VEIN GRAFT TO THE POSTERIOR DESCENDING ARTERY AND THE LEFT INTERNAL MAMMARY ARTERY TO THE LEFT ANTERIOR DESCENDING (LAD). AFTER THE CABG, THE PATIENT'S LEFT VENTRICULAR DYSFUNCTION WAS SEVERELY IMPAIRED IN ADDITION TO THE VENTRICULAR ARRHYTHMIAS MAKING FOR HEMODYNAMICALLY UNSTABLE STATE. PATIENT MAY HAVE AN ELEMENT OF AIRFLOW OBSTRUCTION SECONDARY TO PRIOR SMOKING AS WELL AS SUSPECTED EVIDENCE FOR OBSTRUCTIVE SLEEP APNEA WHICH WILL NEED TO BE INVESTIGATED. THE PATIENT WAS SIGNIFICANTLY FLUID OVERLOADED. THERE WILL BE TRIAL 80 MG INTRAVENOUS (IV) LASIX TO AFFECT DIURESIS. THIS, HOWEVER, MAY BE RATE LIMITING STEP IN ADDITION TO HIS LEFT VENTRICULAR FUNCTION. DURING THE INDEX PROCEDURE, A 3.0 X 13 CYPHER WAS DEPLOYED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND PROXIMAL CIRCUMFLEX. THERE IS MENTION OF A PREVIOUS STENT IN THE CIRCUMFLEX THAT IS PATENT. A 3.0 X 13MM CYPHER STENT WAS THEN DEPLOYED INTO A NEW AREA OF THE PROXIMAL LAD AT 20 ATMOSPHERES FOR 20 SECONDS.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FOR THE (B)(4) STUDY INDICATED THAT APPROXIMATELY FIVE MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH AN ONSET OF PROGRESSION OF CORONARY ARTERY DISEASE. THE PATIENT WAS ADMITTED FOR A CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY AND VALVE SURGERY. THE SURGERY WAS REPORTED TO BE COMPLETED WITH NO COMPLICATIONS AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION SIX DAYS LATER. IN THE OPINION OF THE INVESTIGATOR, THE PROGRESSION OF THE CORONARY ARTERY DISEASE WAS SEVERE IN INTENSITY, NOT RELATED TO THE STUDY DRUG, UNLIKELY RELATED TO THE STUDY DEVICE , AND NOT RELATED TO THE STUDY PROCEDURE. THE PATIENT WAS ADMITTED TO THE INDEX PROCEDURE DUE TO UNSTABLE ANGINA AND UNDERWENT DEPLOYMENT OF TWO DRUG ELUTING STENTS TO THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND THE PROXIMAL CIRCUMFLEX ARTERIES. POST PROCEDURE RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. THE PATIENT WAS DISCHARGED FROM THE INDEX PROCEDURE HOSPITALIZATION THE FOLLOWING DAY.

    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 15140118

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R VITAMIN C 500MG| PRASUGREL (10MG) AND ASPIRIN (81MG)