BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3050690 · Received April 10, 2013

    Report

    Report Number
    2024168-2013-02167
    Event Type
    Death
    Date Received
    April 10, 2013
    Date of Event
    January 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE DEVICE WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF DEATH, MYOCARDIAL INFARCTION, PAIN, ISCHEMIA, PULMONARY EDEMA AND CARDIAC TAMPONADE, AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    ON (B)(6) 2010, DUE TO ACUTE CORONARY SYNDROME, THE SUBJECT UNDERWENT THE INDEX PROCEDURE WITH THE DEPLOYMENT OF ONE DRUG ELUTING / BARE METAL STENT TO LEFT MAIN CORONARY ARTERY SEGMENT. POST PROCEDURE RESIDUAL STENOSIS WAS 0% WITH TIMI III FLOW. ON (B)(6) 2010, THE SUBJECT RECEIVED A PERI-PROCEDURAL LOADING DOSE OF THE THIENOPYRIDINE MEDICATION PRASUGREL 30 MG. ON (B)(6) 2010, AT THE START OF THE STUDY THE SUBJECT RECEIVED THE STUDY MEDICATION MAINTENANCE DOSE OF PRASUGREL 50 MG. ON (B)(6) 2010, THE SUBJECT WAS STARTED ON ASPIRIN 325 MG AND WAS DISCHARGED. THE SITE REPORTED THAT, THE SUBJECTS RANDOMIZATION VISIT WAS OUT OF WINDOW AND THUS THE SUBJECT WAS NOT RANDOMIZED. ON (B)(6) 2013 THE SUBJECT EXPERIENCED RECURRENT ISCHEMIC SYMPTOMS LASTING 10 MINUTES OR MORE WITH NEW ST ELEVATION/DEPRESSION. CARDIAC ENZYMES, A REPEAT ANGIOGRAPHY, AND A ECHOCARDIOGRAM WERE PERFORMED AS A RESULT OF THE EVENT. ON (B)(6) 2013, THE SUBJECT EXPERIENCED THE EVENT OF EMBOLUS IN RIGHT FEMORAL ARTERY, 924 DAYS FOLLOWING THE INDEX PROCEDURE. THE EVENT WAS REPORTED WITH THE SERIOUS CRITERIA INITIAL/PROLONGED HOSPITALIZATION. UPON PRESENTATION TO THE EMERGENCY DEPARTMENT, THE SUBJECT HAD COMPLAINTS OF RIGHT LOWER EXTREMITY WEAKNESS AND PAIN. ON (B)(6) 2013, THE SUBJECTS ELECTROCARDIOGRAM REVEALED SINUS TACHYCARDIA, LEFT AXIS DEVIATION, NONSPECIFIC INTRA-VENTRICULAR BLOCK, ANTERIOLATERAL INFARCTION OF AGE UNDETERMINED AND HAD ABNORMAL ECHOCARDIOGRAM (ECG). ON (B)(6) 2013, THE SUBJECTS DOPPLER DUPLEX IMAGING SHOWED COMPLETE OCCLUSION OF THE RIGHT COMMON FEMORAL ARTERY WITH CLOT EXTENDING THROUGH THE RIGHT FEMORAL ARTERY TO THE RIGHT POPLITEAL ARTERY. ON (B)(6) 2013, THE SUBJECTS LAB RESULTS REVEALED CPK 505 U/L (REFERENCE RANGE: 0 - 175 U/L), CK-MB 10.1 NG/ML (REFERENCE RANGE: 0.0-2.8 NG/ML), TROPONIN T 10.33 NG/ ML (REFERENCE RANGE: GREATER THAN 0.09 NG/ML POSITIVE FOR MYOCARDIAL DAMAGE). ON (B)(6) 2013, THE SUBJECTS CHEST X-RAY SHOWED NEW PERIPHERAL AIRSPACE DISEASE CONSISTENT WITH PULMONARY EDEMA, AN ENDOTRACHEAL TUBE TERMINATES AT THE THORACIC INLET AND NO PNEUMOTHORAX OR PLEURAL EFFUSION IDENTIFIED. ON (B)(6) 2013, THE SUBJECT UNDERWENT RIGHT LOWER EXTREMITY EMBOLECTOMY EMBOLUS WITHIN SUPERFICIAL FEMORAL ARTERY WITH THROMBUS IN THE COMMON FEMORAL AND PROFUNDA ARTERIES. THE SUBJECTS OPERATIVE PROGRESS REPORT NOTE REVEALED THAT, BRONCHOSCOPY WAS DONE TO EVALUATE FOR BLOOD TINGED SECRETIONS WHICH SHOWED NO CRITICAL LESIONS. DUE TO THE CONCERN OF DISTAL EMBOLISM, THE SUBJECT DID NOT UNDERGO THROMBOLYSIS WITH ANGIOGRAM. IN THE OPERATING ROOM, PRE-OPERATIVELY FOLLOWING INTUBATION AND INDUCTION WITH ETOMIDE AND SUCCINYLCHOLINE, THE SUBJECT BECAME BRADYCARDIC, AND THEN WENT TO ASYSTOLIC CARDIAC ARREST; FOR WHICH CPR WAS PERFORMED FOR APPROXIMATELY 3 MINUTES. THE SUBJECT RECEIVED EPINEPHRINE (X1), BICARB AMP (X1) AND CALCIUM WITH RETURN OF SPONTANEOUS CIRCULATION. ON (B)(6) 2013, THE SUBJECTS ECHOCARDIOGRAM REVEALED MODERATELY DEPRESSED LV SYSTOLIC FUNCTION WITH EJECTION FRACTION OF 35 0/0, ANTEROSEPTAL HYPOKINESIS WITH APICAL AKINESIS, MODERATE LV DIASTOLIC DYSFUNCTION SUGGESTING ELEVATED LEFT ATRIAL PRESSURE, SMALL PERICARDIAL EFFUSION WITHOUT EVIDENCE OF TAMPONADE, AORTIC SCLEROSIS, MITRAL VALVE THICKENED AND COMPARED TO PREVIOUS STUDY ON (B)(6) 2013, LEFT VENTRICULAR SYSTOLIC FUNCTION IS MODERATELY DEPRESSED WITH EJECTION FRACTION 35 0/0 ON (B)(6) 2013, THE SUBJECTS COMPUTED TOMOGRAPHY OF HEAD SHOWED NO EVIDENCE TO SUGGEST ANOXIC/HYPOXIC EVENT. ON (B)(6) 2013, THE SUBJECTS TRANS-ESOPHAGEAL ECHO SHOWED NO CARDIOLOGY ETIOLOGY FOR SYSTEMIC EMBOLI. (B)(6) 2013, THE SUBJECT EXPERIENCED THE EVENT OF CARDIAC ARREST, 935 DAYS FOLLOWING THE INDEX PROCEDURE. THE SUBJECT REMAINED IN THE ICU POST PROCEDURE ON CONTINUED MEDICAL MANAGEMENT AND WAS POORLY RESPONSIVE TO STIMULI. THE SUBJECT IMMEDIATE FAMILY ELECTED TO MAKE THE SUBJECT DO NOT RESUSCITATE (DNR). THE SUBJECT EXPIRED ON (B)(6) 2013 DUE TO MULTI-ORGAN FAILURE. AN AUTOPSY WAS DENIED BY THE SUBJECT FAMILY. THE INVESTIGATOR CONSIDERED THE EVENT OF CARDIAC ARREST AS SEVERE IN INTENSITY, NOT RELATED TO STUDY DRUG, NOT RELATED TO STUDY DEVICE AND NOT RELATED TO STUDY PROCEDURE. THE SITE PROVIDED THE INVESTIGATORS CAUSALITY ASSESSMENT OF THE EVENT EMBOLUS IN THE RIGHT FEMORAL ARTERY AS, SEVERE IN INTENSITY, NOT RELATED TO STUDY DRUG, NOT RELATED TO STUDY DEVICE AND NOT RELATED TO STUDY PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152227 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death