BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1686055 · Received May 13, 2010

    Report

    Report Number
    9616099-2010-00360
    Event Type
    Death
    Date Received
    May 13, 2010
    Date of Event
    November 11, 2009
    Report Date
    April 21, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND IS THEREFORE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA THAT (B) (4) STUDY THAT APPROXIMATELY THREE MONTHS POST CAROTID ARTERY STENTING WITH IMPLANTATION OF A PRECISE STENT, THE PATIENT DIED. IT WAS INDICATED AS UNRELATED TO THE CORDIS PRODUCT AND UNRELATED TO THE INDEX PROCEDURE; HOWEVER, THERE IS NO INFORMATION REGARDING THE CAUSE OF DEATH. AT BASELINE THE (B) (6) MALE WAS SYMPTOMATIC WITH A 75% STENOSIS IN THE OSTIUM OF THE INTERNAL CAROTID ARTERY. THE BASELINE (B) (4) STROKE SCORE WAS 0 AND RANKIN SCORE WAS 1 WITH A HISTORY OF TRANSIENT ISCHEMIC ATTACK (TIA). MEDICAL HISTORY INCLUDED HYPERLIPIDEMIA, CABG, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, CORONARY PERCUTANEOUS REVASCULARIZATION, AND HYPERTENSION. THE LESION LENGTH WAS 10MM. THERE WAS SEVERE CONCENTRIC CALCIFICATION, MODERATE TORTUOSITY AND INDICATED AS ULCERATED. THERE WAS NO TARGET LESION THROMBOSIS. A 6MM ANGIOGUARD WAS SUCCESSFULLY DEPLOYED WITHOUT TECHNICAL DIFFICULTY. THE LESION WAS PRE-DILATED WITH NO DOCUMENTED RESISTANCE OR DISSECTION. A 7 X 40MM PRECISE PRO RX STENT WAS DEPLOYED AT THE TARGET LESION WITH NO MALFUNCTION AND NO ASSOCIATED MAJOR ADVERSE EVENT. THE TOTAL STENTED SEGMENT WAS 40MM. THE FINAL TARGET LESION STENOSIS WAS 0. THE ANGIOGUARD RX WAS SUCCESSFULLY RETRIEVED WITHOUT TECHNICAL DIFFICULTY OR ASSOCIATED ADVERSE EVENT. THE PATIENT WAS DISCHARGED THE NEXT DAY. ANTIPLATELET THERAPY INCLUDED PRE AND POST PROCEDURE AND DISCHARGE CLOPIDOGREL AND ASPIRIN. THERE WAS NO ADVERSE EVENT REPORTED DURING THE 30 DAYS FOLLOW UP WITH STROKE SCORES UNCHANGED FROM BASELINE. APPROXIMATELY 3 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT DIED. THE DEATH CERTIFICATE IS NOT AVAILABLE AND THERE IS NO FURTHER INFORMATION REGARDING THE EVENT. THE PRODUCT WAS IMPLANTED IN THE PATIENT AND WAS THEREFORE NOT AVAILABLE FOR EVALUATION. 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 14147004 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON THE LACK OF INFORMATION PERTAINING TO THE REPORTED DEATH IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. THE PATIENT¿S SIGNIFICANT MEDICAL HISTORY AND ADVANCED AGE PUT HIM AT AN INCREASED RISK FOR MAJOR ADVERSE EVENTS.

    Description of Event or Problem · 1

    AS REPORTED BY (B)(4) REGISTRY, THE PATIENT WAS DIAGNOSED WITH A TRANSIENT ISCHEMIC ATTACK (TIA) WHICH OCCURRED DURING POST DILATION. APPROXIMATELY SEVEN HOURS POST PROCEDURE THE PATIENT HAD GRADUAL APHASIA, DYSARTHRIA AND RIGHT HEMIPARESIS. THE PATIENT WAS DEEMED TO HAVE HAD CEREBRAL HYPOPERFUSION. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED A 95% STENOSIS OF THE LEFT PROXIMAL OF INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS 25MM IN LENGTH, MILDLY CALCIFIED. THE REFERENCE VESSEL WAS 8MM IN DIAMETER. THE PATIENT'S PRE-PROCEDURE STROKE SCALE SCORES WERE 0. THE PATIENT WAS ASYMPTOMATIC. AN ANGIOGUARD WITH AN 8MM BASKET WAS DEPLOYED BEYOND THE LESION, AFTER BEING PRE-DILATED. AN 8 X 30MM PRECISE PRO RX STENT WAS IMPLANTED AT THE TARGET LESION, WITH 0% RESIDUAL STENOSIS. DURING POST DILATION THE PATIENT EXPERIENCED APHASIA AND RIGHT HEMIPARESIS. THE PATIENT WAS DIAGNOSED WITH A TRANSIENT ISCHEMIC ATTACK (TIA). THE ONSET WAS SUDDEN AND THE PATIENT FULLY RECOVERED BY THE END OF THE PROCEDURE. EMERGENT SURGERY WAS NOT REQUIRED. THIS EVENT WAS REPORTED TO BE RELATED TO THE CORDIS STENT. APPROXIMATELY SEVEN HOURS POST PROCEDURE THE PATIENT HAD GRADUAL APHASIA, DYSARTHRIA AND RIGHT HEMIPARESIS. THE PATIENT WAS ADMITTED TO THE NEURO INTENSIVE CARE UNIT WITH THE BELIEF THAT HE HAD EXPERIENCED A POST-PROCEDURE STROKE. HOWEVER, CT SCANS WERE NEGATIVE FOR A BLEED, AND POST-PROCEDURE ULTRASOUNDS WERE ALSO NEGATIVE. THE ONSET WAS SUDDEN AND THE PATIENT FULLY RECOVERED WITHOUT TREATMENT 3 DAYS POST-PROCEDURE WITHOUT RESIDUALS. BY DISCHARGE, THE PATIENT WAS DEEMED TO HAVE HAD CEREBRAL HYPOPERFUSION. THE PATIENT WAS DISCHARGED SIX DAYS LATER. THIS EVENT WAS REPORTED TO BE RELATED TO THE INDEX PROCEDURE. PRIOR TO THE PROCEDURE, THE PATIENT HAD NO PRIOR NEUROLOGICAL SYMPTOMS AND THEIR NIHSS PRE-PROCEDURE WAS 0/42. THROMBUS WAS NOT NOTED PRE OR POST STENT DEPLOYMENT.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FROM THE (B) (4) STUDY INDICATED THAT THE PATIENT WAS ADMITTED SYMPTOMATIC WITH A 75% STENOSIS IN THE OSTIUM OF THE INTERNAL CAROTID ARTERY. THE LESION HAD SEVERE CONCENTRIC CALCIFICATION, MODERATE TORTUOSITY AND ULCERATED. A 7 X 40MM PRECISE PRO RX STENT WAS DEPLOYED WITH NO MALFUNCTION AND NO ASSOCIATED MAJOR ADVERSE EVENT. AN ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED AND RETRIEVED DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED THE NEXT DAY. THERE WAS NO ADVERSE EVENT REPORTED DURING THE 30 DAYS FOLLOW UP. APPROXIMATELY 3 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT REPORTED. THE EVENT WAS REPORTED TO BE UNRELATED TO THE CORDIS PRODUCT AND THE INDEX PROCEDURE.

    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 14147004

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death