BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1820868 · Received August 31, 2010

    Report

    Report Number
    9616099-2010-00651
    Event Type
    Death
    Date Received
    August 31, 2010
    Date of Event
    July 21, 2010
    Report Date
    August 17, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM THE (B)(4) STUDY STATES THAT THREE DAYS POST RIGHT CAROTID PRECISE STENTING FOLLOWED BY CORONARY ARTERY REVASCULARIZATION SURGERY, THE PATIENT DIED. AT INDEX PROCEDURE, THE (B)(6) MALE WAS ADMITTED WITH CHEST SORENESS ON THE LEFT SIDE WITH SOME LOCAL NUMBNESS. A CAROTID DOPPLER SHOWED A LEFT INTERNAL CAROTID OCCLUSION. ADDITIONALLY A CARDIAC CATHETERIZATION SHOWED THAT THE PATIENT NEEDED CORONARY ARTERY BYPASS. THE PHYSICIAN REVIEWED THE ULTRASOUND AND DETERMINED THAT THE PATIENT ALSO NEEDED STENTING OF THE RIGHT CAROTID ARTERY WHICH HAD A 95% SEVERELY CALCIFIED CONCENTRIC AND CIRCUMFERENTIAL STENOSIS. THIS STENTING PROCEDURE OF THE 30MM OSTIAL RIGHT INTERNAL CAROTID LESION WAS PERFORMED TWO DAYS LATER WITH SUCCESSFUL DEPLOYMENT AND RETRIEVAL OF AN ANGIOGUARD EMBOLIC PROTECTION DEVICE AND IMPLANTATION OF A 9X40 PRECISE STENT. THERE WAS NO MALFUNCTION OR ASSOCIATED MAJOR ADVERSE EVENT. POST PROCEDURE STENOSIS WAS 5% AND THE PATIENT WAS WITHOUT NEUROLOGICAL DEFICITS WHEN LEAVING THE ANGIOGRAPHY SUITE. ON THE SAME DAY, THE PATIENT UNDERWENT CORONARY BYPASS X3. CORONARY BYPASSING CONSISTED OF LEFT INTERNAL MAMMARY ARTERY TO THE LEFT ANTERIOR DESCENDING, AORTA TO DIAGONAL AND AORTA TO POSTERIOR DESCENDING ARTERY. POST-OP THE PATIENT WAS ADMITTED TO INTENSIVE CARE. THE PATIENT WAS EXTUBATED THE NEXT DAY AND HIS CHEST TUBES WERE REMOVED WITHOUT DIFFICULTY. THE PATIENT'S WIRES WERE REMOVED THE NEXT DAY AND PLAVIX WAS STARTED FOR THE CAROTID STENT. ON THE SAME DAY, THE WIFE NOTICED SOME RIGHT UPPER EXTREMITY WEAKNESS. A CT SCAN OF THE BRAIN WAS PERFORMED AND DID NOT SHOW ANY EVIDENCE OF ACUTE STROKE, MASS, OR HEMORRHAGE. THE PATIENT CONTINUED TO HAVE SYMPTOMS OF RIGHT SIDE WEAKNESS IN ADDITION TO SOME FACIAL DROOPING. THE PATIENT WAS DIAGNOSED WITH LEFT CORONA RADIATE CEREBROVASCULAR ACCIDENT. THE PATIENT WAS PLACED IN THE IN-PATIENT REHAB PROGRAM. THREE DAYS LATER, THE PATIENT HAD HICCUPS, REFLUX AND VOMITING AND THEN ASPIRATED DEVELOPING ASYSTOLE. IT WAS REPORTED THAT A CODE (CARDIOPULMONARY RESUSCITATION) WAS INITIATED. ACCORDING TO THE CHART, THE PATIENT WENT FROM ASYSTOLE TO PULSELESS ELECTRICAL ACTIVITY (PEA). VERY BRIEFLY THE PATIENT HAD A PULSE AND THEN BECAME PULSELESS AGAIN. THE PATIENT EXPIRED EARLY THAT MORNING. AS PER THE PHYSICIAN, THE WEAKNESS THE PATIENT WAS HAVING WAS A RESULT OF LOW FLOW STATE WHILE ON THE BYPASS MACHINE DURING HIS CORONARY REVASCULARIZATION. THE PATIENT EXHIBITED NO NEUROLOGICAL ADVERSE EVENT AFTER THE CAROTID STENT, THE STENTING PROCEDURE WENT VERY WELL AND EXCELLENT RESULTS POST STENT PLACEMENT. THE NEUROLOGICAL DEFICIT APPEARED AFTER THE PATIENT HAD UNDERGONE HIS CORONARY ARTERY BYPASS PROCEDURE. THE STENT REMAINS IMPLANTED. 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. BECAUSE IN ADDITION TO THE RIGHT CAROTID STENTING THE PATIENT HAD A TOTAL LEFT INTERNAL CAROTID OCCLUSION, A RELATIONSHIP TO THE RIGHT CAROTID STENTING CANNOT BE CONCLUSIVELY RULED OUT. STROKE AND DEATH ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THIS TYPE OF PROCEDURE. HOWEVER, AS REPORTED, THE EVENTS APPEAR TO BE RELATED TO LOW FLOW DURING CORONARY REVASCULARIZATION. THE PATIENT'S MEDICAL HISTORY INCLUDING SYNCHRONOUS, SEVERE CARDIAC AND CAROTID DISEASE REQUIRING OPEN-HEART SURGERY AND CAROTID REVASCULARIZATION, AND CONTRALATERAL CAROTID OCCLUSION PLACED HIM AT INCREASED RISK FOR MAJOR ADVERSE EVENT AND ARE FACTORS LIKELY CONTRIBUTING TO THE REPORTED EVENTS. THERE IS NO INDICATION OF ANY PERFORMANCE ISSUES RELATED TO THE PRECISE STENT OR A RELATIONSHIP TO THE PROCEDURE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    AS PER THE PHYSICIAN, THE WEAKNESS THE PATIENT WAS HAVING WAS A RESULT OF LOW FLOW STATE WHILE ON THE BYPASS MACHINE DURING HIS CORONARY REVASCULARIZATION. THE PATIENT EXHIBITED NO NEUROLOGICAL ADVERSE EVENT AFTER THE CAROTID STENT, THE STENTING PROCEDURE WENT VERY WELL AND EXCELLENT RESULTS POST STENT PLACEMENT. THE NEUROLOGICAL DEFICIT APPEARED AFTER THE PATIENT HAD UNDERGONE HIS CORONARY ARTERY BYPASS PROCEDURE. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THEY HAVE BEEN GENERATING DISCREPANT RESULTS FOR MULTIPLE ASSAYS ON THE ARCHITECT C16000 ANALYZER. THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED AN INITIAL SODIUM ASSAY RESULT OF 136 MMOL/L THAT RETESTED AT 180 MMOL/L. NO SUSPECT RESULTS HAVE BEEN REPORTED FROM THE LAB. A SERVICE CALL WAS INITIATED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(4) STUDY STATES THAT THREE DAYS POST INDEX PROCEDURE, THE PATIENT EXPIRED. THE PATIENT IS A (B)(6) MALE WHO WAS ADMITTED WITH CHEST SORENESS ON THE LEFT SIDE WITH SOME LOCAL NUMBNESS. A CAROTID DOPPLER SHOWED A LEFT INTERNAL CAROTID OCCLUSION. A CARDIAC CATH WAS PERFORMED SHOWING THAT THE PATIENT NEEDED CORONARY ARTERY BYPASS. THE PHYSICIAN REVIEWED THE ULTRASOUND AND DETERMINED THAT THE PATIENT ALSO NEEDED STENTING OF THE RIGHT CAROTID ARTERY WHICH HAD A 95% STENOSIS. THIS PROCEDURE WAS PERFORMED TWO DAYS LATER. THE CAROTID STENTING PROCEDURE WENT WELL. ON THE SAME DAY, THE PATIENT UNDERWENT CORONARY BYPASS X3. CORONARY BYPASSING CONSISTED OF LEFT INTERNAL MAMMARY ARTERY TO THE LEFT ANTERIOR DESCENDING, AORTA TO DIAGONAL AND AORTA TO POSTERIOR DESCENDING ARTERY. POST-OP THE PATIENT WAS ADMITTED TO INTENSIVE CARE. THE PATIENT WAS EXTUBATED THE NEXT DAY AND HIS CHEST TUBES WERE REMOVED WITHOUT DIFFICULTY. THE PATIENT'S WIRES WERE REMOVED THE NEXT DAY AND PLAVIX WAS STARTED FOR THE CAROTID STENT. ON THE SAME DAY, THE WIFE NOTICED SOME RIGHT UPPER EXTREMITY WEAKNESS. A CT SCAN OF THE BRAIN WAS PERFORMED AND DID NOT SHOW ANY EVIDENCE OF ACUTE STROKE, MASS, OR HEMORRHAGE. THE PATIENT CONTINUED TO HAVE SYMPTOMS OF RIGHT SIDE WEAKNESS IN ADDITION TO SOME FACIAL DROOPING. THE PATIENT WAS DIAGNOSED WITH LEFT CORONA RADIATE CEREBROVASCULAR ACCIDENT. THE PATIENT WAS PLACED IN THE IN-PATIENT REHAB PROGRAM. THREE DAYS LATER, THE PATIENT HAD HICCUPS, REFLUX AND VOMITING AND THEN ASPIRATED DEVELOPING ASYSTOLE. CODE WAS INITIATED. ACCORDING TO THE CHART THE PATIENT WENT FROM ASYSTOLE TO PEA. VERY BRIEFLY THE PATIENT HAD A PULSE AND THEN BECAME PULSELESS AGAIN. THE PATIENT EXPIRED EARLY THAT MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15111558

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death