BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1663954 · Received April 21, 2010

    Report

    Report Number
    3003742446-2010-00116
    Event Type
    Death
    Date Received
    April 21, 2010
    Date of Event
    March 12, 2010
    Report Date
    March 23, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A (B) (6) FEMALE PASSED AWAY APPROXIMATELY A WEEK POST IMPLANTATION OF A CYPHER STENT. PAST MEDICAL HISTORY INCLUDED DIABETES MELLITUS, HYPERTENSION, COPD, LOBECTOMY OF LEFT LOWER LOBE DUE TO CANCER, CHEMOTHERAPY/RADIOTHERAPY, PNEUMONITIS, ARTHRITIS, PERIPHERAL VASCULAR DISEASE, DEPRESSION AND ANXIETY, RENAL STENOSIS WITH STENTING IN 2004, CHRONIC RENAL INSUFFICIENCY STAGE 3, DIASTOLIC CONGESTIVE HEART FAILURE, AND DIVERTICULOSIS. THE PATIENT WAS INITIALLY ADMITTED WITH ACUTE CORONARY SYNDROME AND AN EMERGENT CORONARY ANGIOGRAPHY REVEALED A LESION WITH 80% STENOSIS IN THE LEFT CIRCUMFLEX ARTERY AND 100% OCCLUSION OF THE RIGHT CORONARY ARTERY WITH LEFT TO RIGHT COLLATERALS. A 3.0X28MM CYPHER STENT WAS IMPLANTED IN THE LEFT CIRCUMFLEX LESION SUCCESSFULLY. FOLLOWING THE PROCEDURE, THE PATIENT¿S RENAL FUNCTION DETERIORATED AND HYDRATION THERAPY WAS STARTED IN MANAGEMENT OF POTENTIAL CONTRAST NEPHROPATHY. HOWEVER, THE PATIENT DEVELOPED ABRUPT ONSET OF SHORTNESS OF BREATH AND IV FLUIDS WERE REDUCED AND LASIX STARTED RESOLVING THE SHORTNESS OF BREATH. A CYPHER STENT WAS IMPLANTED IN THE LEFT CIRCUMFLEX LESION SUCCESSFULLY. ON THE FOLLOWING DAY, THE PATIENT DEVELOPED ATRIAL FIBRILLATION WITH A RAPID RESPONSE AND WAS TREATED WITH RYTHMOL. THE PATIENT ALSO EXPERIENCED PERSISTING NAUSEA REPORTED TO BE MOST LIKELY RELATED TO ACID-PEPTIC DISEASE AND PROTONIX WAS STARTED. THE PATIENT DEVELOPED RELAPSES OF HER ATRIAL FIBRILLATION REQUIRING INTRAVENOUS CARDIZEM. THE PATIENT HAD PROGRESSIVE DYSPNEA THOUGHT TO BE CAUSED BY EXACERBATION OF HER SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). A PULMONARY FUNCTION STUDY REVEALED AN FEV1 38% OF PREDICTED AND FVC 52% PREDICTED. AT THIS TIME, BIPAP SUPPORT WAS STARTED. THE PATIENT¿S HEART RATE DECREASED TO 40¿S BPM WHILE ON BEDPAN. THE PATIENT BECOMES UNRESPONSIVE AND GOES INTO CARDIAC ARREST, HOWEVER RESUSCITATIVE EFFORTS WERE UNSUCCESSFUL. A BEDSIDE ECHOCARDIOGRAPHY SUGGESTED SEVERE MITRAL INSUFFICIENCY NOT PREVIOUSLY DETECTED INDICATING POSSIBLE CAPILLARY MUSCLE RUPTURE. THE CERTIFICATE OF DEATH INDICATES THAT THE CAUSE OF DEATH WAS CARDIOPULMONARY ARREST (PAPILLARY MUSCLE RUPTURE) DUE TO MYOCARDIAL INFARCTION, DUE TO ATHEROSCLEROTIC CORONARY DISEASE. SECONDARY CAUSES INCLUDED RENAL INSUFFICIENCY AND CHRONIC OBSTRUCTIVE LUNG DISEASE. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS, NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THIS PATIENT¿S DEATH. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THE PATIENT¿S CRITICAL MEDICAL STATUS (TOTALLY OCCLUDED RCA, COPD, CHF, RENAL FAILURE) MAY HAVE CONTRIBUTED TO THE UNFORTUNATE DETERIORATION OF HEALTH POST PROCEDURE AND SUBSEQUENT DEATH.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE STUDY (B) (4) ADJUDICATION MINUTES INDICATES ADJUDICATION OF A PROBABLE THROMBOSIS PER ARC DEFINITION RELATED TO PROCEDURE AND TO DEVICE. THE DEATH OF THIS (B) (6) FEMALE APPROXIMATELY A WEEK POST IMPLANTATION OF A CYPHER STENT WAS PREVIOUSLY REPORTED. THE PATIENT WAS INITIALLY ADMITTED WITH ACUTE CORONARY SYNDROME AND AN EMERGENT PCI WAS PERFORMED TO TREAT A LESION WITH 80% STENOSIS IN THE LEFT CIRCUMFLEX ARTERY WITH THE IMPLANTATION OF A 3.0X28MM CYPHER STENT. THERE WAS 100% OCCLUSION OF THE RIGHT CORONARY ARTERY WITH LEFT TO RIGHT COLLATERALS. PAST MEDICAL HISTORY INCLUDED DIABETES MELLITUS, HYPERTENSION, COPD, LOBECTOMY OF LEFT LOWER LOBE DUE TO CANCER, CHEMOTHERAPY/RADIOTHERAPY, PNEUMONITIS, ARTHRITIS, PERIPHERAL VASCULAR DISEASE, DEPRESSION AND ANXIETY, RENAL STENOSIS WITH STENTING IN 2004, CHRONIC RENAL INSUFFICIENCY STAGE 3, DIASTOLIC CONGESTIVE HEART FAILURE, AND DIVERTICULOSIS. FOLLOWING THE PROCEDURE, THE PATIENT'S RENAL FUNCTION DETERIORATED AND HYDRATION THERAPY WAS STARTED IN MANAGEMENT OF POTENTIAL CONTRAST NEPHROPATHY. HOWEVER, THE PATIENT DEVELOPED ABRUPT ONSET OF SHORTNESS OF BREATH AND IV FLUIDS WERE REDUCED AND LASIX STARTED RESOLVING THE SHORTNESS OF BREATH. ON THE FOLLOWING DAY, THE PATIENT DEVELOPED ATRIAL FIBRILLATION WITH A RAPID RESPONSE AND WAS TREATED WITH RYTHMOL. THE PATIENT ALSO EXPERIENCED PERSISTING NAUSEA REPORTED TO BE MOST LIKELY RELATED TO ACID-PEPTIC DISEASE AND PROTONIX WAS STARTED. THE PATIENT DEVELOPED RELAPSES OF HER ATRIAL FIBRILLATION REQUIRING INTRAVENOUS CARDIZEM. THE PATIENT HAD PROGRESSIVE DYSPNEA THOUGHT TO BE CAUSED BY EXACERBATION OF HER SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). A PULMONARY FUNCTION STUDY REVEALED AN FEV1 38% OF PREDICTED AND FVC 52% PREDICTED. AT THIS TIME, BIPAP SUPPORT WAS STARTED. THE PATIENT'S HEART RATE DECREASED TO 40'S BPM WHILE ON BEDPAN. THE PATIENT BECOMES UNRESPONSIVE AND GOES INTO CARDIAC ARREST, HOWEVER RESUSCITATIVE EFFORTS WERE UNSUCCESSFUL. A BEDSIDE ECHOCARDIOGRAPHY SUGGESTED SEVERE MITRAL INSUFFICIENCY NOT PREVIOUSLY DETECTED INDICATING POSSIBLE CAPILLARY MUSCLE RUPTURE. THE CERTIFICATE OF DEATH INDICATES THAT THE CAUSE OF DEATH WAS CARDIOPULMONARY ARREST (PAPILLARY MUSCLE RUPTURE) DUE TO MYOCARDIAL INFARCTION, DUE TO ATHEROSCLEROTIC CORONARY DISEASE. SECONDARY CAUSES INCLUDED RENAL INSUFFICIENCY AND CHRONIC OBSTRUCTIVE LUNG DISEASE. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THROMBOTIC EVENTS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY ARTERY STENTING. HOWEVER, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE ADJUDICATED PROBABLE THROMBOTIC EVENT. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THE PATIENT'S CRITICAL MEDICAL STATUS (TOTALLY OCCLUDED RCA, COPD, CHF, RENAL FAILURE) MAY HAVE CONTRIBUTED TO THE UNFORTUNATE DETERIORATION OF HEALTH POST PROCEDURE AND SUBSEQUENT DEATH.

    Description of Event or Problem · 1

    A PATIENT INITIALLY ENROLLED IN THE (B) (6) STUDY DEVELOPED ATRIAL FIBRILLATION, EXACERBATED CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), AND CONGESTIVE HEART FAILURE (CHF) APPROXIMATELY TWO DAYS POST INDEX PROCEDURE. THE PATIENT WAS INTUBATED AND ADMITTED TO THE ICU WHERE THEY DEVELOPED RESPIRATORY ARREST AND DIED APPROXIMATELY SIX DAYS POST PROCEDURE. THE PATIENT WAS ADMITTED WITH UNSTABLE ANGINA PECTORIS TYPE II. THE PATIENT HAD 80% STENOSIS OF THE PROXIMAL CIRCUMFLEX. THE LESION WAS DESCRIBED AS 20MM IN LENGTH AND WAS DE NOVO. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER. PRIOR TO STENT IMPLANTATION, PRE-DILATION WAS PERFORMED WITH A NON-CORDIS BALLOON. A 3.00 X 28 CYPHER US RX STENT WAS THEN IMPLANTED AT THE TARGET LESION AT 16ATM AND POST-DILATED AS USUAL. POST PROCEDURE DIAMETER OF STENOSIS WAS 0%. PRE AND POST PROCEDURE TIMI FLOW WAS 3.

    Description of Event or Problem · 1

    PER CEC ADJUDICATION, THE EVENT PROBABLE STENT THROMBOSIS WAS RELATED TO PROCEDURE AND TO DEVICE.

    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 15093792

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| H| L