BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1662222 · Received April 20, 2010

    Report

    Report Number
    9616099-2010-00286
    Event Type
    Death
    Date Received
    April 20, 2010
    Date of Event
    March 17, 2009
    Report Date
    March 24, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT INDEX PROCEDURE, THE PATIENT HAD A HISTORY OF SEVERE PULMONARY DISEASE, CLINICAL COPD, HISTORY OF SMOKING (>5PACKS OF CIGARETTES), CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, AND HYPERTENSION (SYSTOLIC>140). THERE WAS NO CONTRALATERAL OCCLUSION. THE TARGET LESION WAS THE PROXIMAL LEFT ICA WITH A LESION LENGTH OF 20MM WITH A STENOSIS OF 90%. THE REFERENCE VESSEL WAS 5.5. THERE WAS NO TARGET LESION THROMBOSIS AND THE LESION WAS CONCENTRIC WITH MILD CALCIFICATION AND ARCH TYPE I WITH MILD VESSEL TORTUOSITY. THE DATA BASE DOES NOT INDICATE DEPLOYMENT OF ANY EMBOLIC PROTECTION DEVICE AND NO INDICATION OF ANY MALFUNCTION RELATED TO AN EMBOLIC PROTECTION DEVICE. THE LESION WAS PREDILATED WITH NO RESISTANCE TO PTA AND NO DISSECTION DOCUMENTED. THE 7.0 X 30 PRECISE STENT WAS DEPLOYED AT THE TARGET LESION WITHOUT MALFUNCTION AND NO ASSOCIATED MAJOR ADVERSE EVENT. THE TOTAL LENGTH OF STENTED SEGMENT WAS 30MM WITH A FINAL TARGET LESION PERCENT DIAMETER STENOSIS INDICATED AS 20%. THE FOLLOWING DAY, THE (B) (6) STROKE SCALE SCORE WAS INDICATED AS A 3; HOWEVER, WITH FOLLOW-UP INVESTIGATION, IT WAS REPORTED THAT THERE WAS NO CHANGE IN THE PATIENT¿S NEUROLOGICAL STATUS FROM BASELINE TO DISCHARGE. THE PATIENT WAS DISCHARGE ON POST PROCEDURE DAY TWO; MEDICATIONS INCLUDED PRE & POST PROCEDURE AND DISCHARGE CLOPIDOGREL AND PRE-PROCEDURE AND DISCHARGE ASPIRIN. IT WAS INDICATED AT DISCHARGE THERE WERE NO MAJOR ADVERSE EVENTS AND THE PATIENT WAS ASYMPTOMATIC. AT 30 DAY FOLLOW-UP THE DATA INDICATED (B) (6) STROKE SCALE SCORE 0 AND (B) (6) SCORE 0. MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. IT WAS INDICATED THAT THERE WERE NO ADVERSE EVENTS. THE STENT REMAINS IMPLANTED AND IS THEREFORE NOT AVAILABLE 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 14000243 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. MANUFACTURING RECORDS FOR LOT 14000243 WERE REVIEWED AND PRODUCT MET ALL QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. A DHR REVIEW WAS REQUESTED TO NITINOL DEVICES & COMPONENTS (NDC), FOR PART NUMBER: 23540 AND STENT LOT NUMBERS 118687, 118845, 118657 AND 118511; AND THE RESULTS INDICATE THAT THE STENT SHIPPED MEETS SPECIFIED RELEASE REQUIREMENTS. WITH THE LACK OF INFORMATION PERTAINING TO THE PATIENT¿S DEATH APPROXIMATELY SEVEN WEEKS POST CAROTID ARTERY STENTING, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. THE PATIENT¿S EXTENSIVE CARDIAC AND PULMONARY MEDICAL HISTORY MAY HAVE CONTRIBUTED. 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; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED VIA THE (B) (4) STUDY THAT APPROXIMATELY SEVEN WEEKS POST TREATMENT OF A LEFT INTERNAL CAROTID ARTERY (ICA) STENOSIS WITH A PRECISE STENT (PC0730RXC/LOT 14000243) THE PATIENT DIED OF UNKNOWN CAUSE. THE SITE REPORTED THAT THE PATIENT DIED AT HOME WITH NO FURTHER INFORMATION. HOWEVER, IT WAS REPORTED THAT SHORTLY AFTER THE PROCEDURE, THE PATIENT WAS DIAGNOSED WITH LUNG CANCER, BUT IT IS UNKNOWN IF THIS WAS THE CAUSE OF DEATH.

    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 14000243

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death