BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1677854 · Received May 10, 2010

    Report

    Report Number
    9616099-2010-00345
    Event Type
    Death
    Date Received
    May 10, 2010
    Date of Event
    July 1, 2009
    Report Date
    April 23, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO MONTHS AFTER THE PROCEDURE, THE PATIENT WAS HOSPITALIZED FOR URETERAL STENT SURGERY, AND DEVELOPED LEFT-SIDED WEAKNESS/HEMIPARESIS AND BEHAVIOR CHANGE. A CT OF THE HEAD SHOWED A NEW RIGHT PARIETAL INFARCT. SHE ALSO DEVELOPED SEPSIS AND WAS TREATED WITH IV FLUIDS AND IV PRESSORS. SHE EXPIRED LATER THAT MORNING WITH THE CAUSE OF DEATH FELT TO BE SEPSIS, WITH SECONDARY CAUSE OF DEATH ACUTE RIGHT PARIETAL ISCHEMIC STROKE WITH LEFT HEMIPARESIS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00343 AND 9616099-2010-00345. COMPLAINT CONCLUSION: TWO MONTHS AFTER HAVING A STENT PLACED IN THE RIGHT INTERNAL CAROTID ARTERY, THE PATIENT EXPIRED WITH THE CAUSE OF DEATH FELT TO BE SEPSIS, WITH SECONDARY CAUSE OF ACUTE RIGHT PARIETAL STROKE WITH LEFT HEMIPARESIS. THE PATIENT DEVELOPED TRANSIENT HYPOTENSION FOLLOWING THE PROCEDURE THAT WAS TREATED WITH DOPAMINE AND SALINE BOLUS. THE PATIENT WAS DISCHARGED APPROXIMATELY 17 DAYS AFTER THE INDEX PROCEDURE. TWO MONTHS AFTER THE PROCEDURE, THE PATIENT WAS HOSPITALIZED FOR URETERAL STENT SURGERY, AND DEVELOPED LEFT-SIDED WEAKNESS/HEMIPARESIS. A CT OF THE HEAD SHOWED A NEW RIGHT PARIETAL INFARCT. SHE ALSO DEVELOPED SEPSIS AND WAS TREATED WITH IV FLUIDS AND IV VASOPRESSORS. SHE EXPIRED LATER THAT MORNING WITH THE CAUSE OF DEATH FELT TO BE SEPSIS, WITH SECONDARY CAUSE OF DEATH ACUTE RIGHT PARIETAL STROKE WITH LEFT HEMIPARESIS. THE PATIENT¿S MEDICAL HISTORY INCLUDES STROKE, PREVIOUS RIGHT AND LEFT ENDARTERECTOMY, HYPERLIPIDEMIA, CLINICAL COPD, ABNORMAL STRESS TEST, PAST SMOKING ,CORONARY ARTERY DISEASE, HYPERTENSION, FOCAL RIGHT RETROPERITONEAL FIBROSIS STATUS POST AORTOBIFEMORAL BYPASS (2004) RIGHT HYDRONEPHROSIS AND CHRONIC RIGHT URETERAL STENT CHANGES, LEFT HYDRONEPHROSIS, MITRAL REGURGITATION, HYPOTHYROIDISM, GASTROESOPHAGEAL REFLUX DISEASE, ANEMIA, PERIPHERAL VASCULAR DISEASE. THE DEVICE WAS NOT RETURNED 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 13469407 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT HYPOTENSION OF PATIENTS UNDERGOING CAS IS A WELL KNOWN AND DOCUMENTED POTENTIAL SIDE EFFECT AND 40% OF PATIENT¿S SUSTAINED A REACTION SECONDARY TO CAROTID BODY STIMULATION DURING BALLOON INFLATION, MOST COMMONLY SHORT-TERM HYPOTENSION WITHOUT CLINICAL SYMPTOMS, NOT ASSOCIATED TO PERIPROCEDURAL CEREBRAL COMPLICATIONS. STROKE IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY. THE ACT OF POST-DILATATION, TO OPTIMALLY OPPOSE A CAROTID STENT TO THE VESSEL WALL, TEMPORARILY OBSTRUCTS BLOOD FLOW TO THE CEREBRAL ARTERIES (ISCHEMIC PROCESS). STROKE IS ASSOCIATED WITH A STOPPAGE OR SLOWING OF BLOOD FLOW TO THE CEREBRAL ARTERIES. THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT MAY TRAVEL UPSTREAM TO THE CEREBRAL ARTERIES POTENTIALLY DISRUPTING PERFUSION. THIS ACT, INHERENT TO THE PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT¿S SIGNIFICANT MEDICAL HISTORY MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B) (4) REGISTRY, A PATIENT EXPERIENCED HYPOTENSION FOLLOWING THE INDEX PROCEDURE AND EXPIRED DUE TO SEPSIS AND STROKE APPROXIMATELY 2 MONTHS AFTER THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 99% STENOSIS IN THE OSTIAL RIGHT INTERNAL CAROTID ARTERY AND 60% STENOSIS IN THE DISTAL COMMON CAROTID ARTERY. THE INTERNAL CAROTID ARTERY LESION WAS A RESTENOSIS OF A PREVIOUS ENDARTERECTOMY AND WAS DESCRIBED AS 5MM IN LENGTH, MILDLY CALCIFIED, AND ECCENTRIC. THE REFERENCE VESSEL WAS 6.0MM IN DIAMETER AND MILDLY TORTUOUS. THE DISTAL COMMON CAROTID ARTERY LESION WAS 15MM IN LENGTH AND THE REFERENCE VESSEL WAS 6MM IN DIAMETER. AN ANGIOGUARD RX WITH A 6MM BASKET WAS DEPLOYED BEYOND THE TARGET LESIONS AND THE LESION WAS PRE-DILATED. AN 8.0 X 30MM PRECISE RX STENTS WAS IMPLANTED IN THE INTERNAL CAROTID ARTERY AND A 10.0 X 30MM PRECISE RX STENT WAS IMPLANTED AT THE DISTAL COMMON CAROTID ARTERY LESION. THERE WAS NO RESIDUAL STENOSIS. THE ANGIOGUARD WAS REMOVED WITH NO DEBRIS NOTED IN THE BASKET. THE PATIENT LATER DEVELOPED TRANSIENT HYPOTENSION FOLLOWING THE PROCEDURE THAT WAS TREATED WITH DOPAMINE AND SALINE BOLUS.

    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 13469407

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| R ASPIRIN, CLOPIDOGREL, HEPARIN