BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1843442 · Received September 24, 2010

    Report

    Report Number
    9616099-2010-00717
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    May 7, 2009
    Report Date
    January 26, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DOPPLER STUDY REVEALED BILATERAL STENTS WERE OPEN AND PATENT, BUT DISTAL TO THE STENT ON THE LEFT SHOWED A 75% STENOSIS. THE PEAK SYSTOLIC VELOCITIES WITHIN THE RIGHT INTERNAL CAROTID ARTERY WERE INCREASED WITH NO EVIDENCE OF STENOSIS. THE DURATION OF THE NEUROLOGICAL DEFICITS WAS PERMANENT AND RECOVERY WAS PARTIAL WITH MAJOR RESIDUAL. THE PATIENT WAS DISCHARGED APPROXIMATELY 12 DAYS AFTER THE ONSET OF SYMPTOMS TO A REHABILITATION FACILITY. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT OR THE INDEX PROCEDURE. COMPLAINT CONCLUSION: THE ADJUDICATION MINUTES RECEIVED 9/3/2010 AGREE WITH THE PREVIOUS DIAGNOSIS OF AN ISCHEMIC STROKE. HOWEVER, NEW INFORMATION NOTES THAT THE STROKE MAY HAVE OCCURRED ON THE IPSILATERAL SIDE, OR THE SAME SIDE AS THE PREVIOUSLY PLACED STENT. THIS EVENT WAS REPORTED TO HAVE OCCURRED 3 MONTHS POST INDEX PROCEDURE AND 2 DAYS POST OPEN HEART VALVE REPLACEMENT SURGERY. THE PATIENT UNDERWENT A PORCINE VALVE REPLACEMENT FOR AORTIC VALVE STENOSIS. HE DID WELL THROUGH THE SURGERY, BUT POST-SURGERY, AFTER EXTUBATION HE WAS CONFUSED AND BECAME SOMEWHAT COMBATIVE. THE NEUROLOGIST'S IMPRESSION REGARDING THE NEUROLOGICAL FINDINGS WAS: RIGHT CEREBRAL CORTICAL INFARCTION INVOLVING THE RIGHT PARIETAL LOBE WITH NEGLECT OF THE LEFT SIDE AND MINIMAL WEAKNESS ON THAT SIDE. THE DURATION OF THE NEUROLOGICAL DEFICITS WAS PERMANENT AND RECOVERY WAS PARTIAL WITH MAJOR RESIDUAL. A CAROTID DUPLEX STUDY FOUR DAYS AFTER THE SYMPTOMS BEGAN REVEALED THE STENT IN THE RIGHT INTERNAL CAROTID ARTERY REMAINED PATENT. PRODUCT WAS IMPLANTED AND NO 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 13306435 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. EMBOLIC STROKES ARE USUALLY CAUSED BY AN EMBOLUS (A BLOOD CLOT THAT FORMS ELSEWHERE IN THE BODY AND TRAVELS THROUGH THE BLOODSTREAM TO THE BRAIN) THAT TRAVELS FROM OTHER PARTS OF THE BODY TO THE NECK OR BRAIN AND BLOCKS A BLOOD VESSEL. EMBOLIC STROKES OFTEN RESULT FROM HEART DISEASE OR HEART SURGERY AND OCCUR RAPIDLY AND WITHOUT ANY WARNING SIGNS. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. ALTHOUGH IT IS LIKELY THAT THE ETIOLOGY OF THE STROKE WAS DUE TO PROCEDURAL OR PHARMACEUTICAL ISSUES RELATED TO THE MAJOR SURGERY 2 DAYS PRIOR TO INITIAL SYMPTOMS, INVOLVEMENT OF THE PREVIOUSLY PLACED STENT CANNOT BE COMPLETELY RULED OUT. AS SUCH, THE STOKE OCCURRING (B)(6) 2009 WILL BE MADE A REPORTABLE COMPLAINT.

    Description of Event or Problem · 1

    THIS (B)(4) REGISTRY EVENT WAS INITIALLY CONSIDERED NON-REPORTABLE, BUT THE EVENT IS NOW BEING REPORTED BASED ON ADDITIONAL INFORMATION RECEIVED VIA ADJUDICATION MINUTES ON 9/3/2010. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS ECCENTRIC, ULCERATED, 15MM IN LENGTH, 95% STENOSED, WITH MILD CALCIFICATION. THE REFERENCE VESSEL WAS 4MM IN DIAMETER AND MILDLY TORTUOUS. A 5MM ANGIOGUARD RX WAS DEPLOYED BEYOND THE TARGET LESION. THE LESION WAS PRE-DILATED AND A 7 X 40MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED AT THE TARGET LESION. THE ANGIOGUARD WAS RETRIEVED WITH NO DEBRIS NOTED IN THE BASKET. RESIDUAL STENOSIS WAS 10%. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. APPROXIMATELY TWO AND A HALF MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT A VALVE REPLACEMENT FOR AORTIC VALVE STENOSIS. HE DID WELL THROUGH THE SURGERY, BUT APPROXIMATELY TWO DAYS POST-SURGERY, AFTER EXTUBATION, HE WAS CONFUSED AND BECAME SOMEWHAT COMBATIVE. THE NEUROLOGIST'S IMPRESSION WAS THAT THE PATIENT HAD EXPERIENCED A RIGHT CEREBRAL CORTICAL INFARCTION INVOLVING THE RIGHT PARIETAL LOBE WITH NEGLECT OF THE LEFT SIDE AND MINIMAL WEAKNESS ON THAT SIDE.

    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 13306435

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention| S 6FR SHUTTLE SHEATH, 5MM ANGIOGUARD RX.