BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2880125 · Received December 19, 2012

    Report

    Report Number
    9616099-2012-00756
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    September 26, 2012
    Report Date
    December 4, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE (B)(6), THE PATIENT EXPERIENCED A STROKE THE SAME DAY AS THE INDEX PROCEDURE. THE PATIENT IS AN (B)(6) MALE WHO WAS ENROLLED IN THE (B)(6) FOR STENTING OF THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS ECCENTRIC AND ULCERATED WITH MILD CALCIFICATION AND A 70% STENOSIS. AN ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS POSITIONED DISTAL TO THE LESION FOLLOWED BY DEPLOYMENT OF A PRECISE STENT. THE FILTER WAS REMOVED FROM THE PATIENT AND UPON INSPECTION DEBRIS WAS FOUND IN THE FILTER BASKET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ON THE NIGHT OF THE PROCEDURE (6-12 HOURS LATER) THE PATIENT SUFFERED GRADUAL ONSET BEHAVIORAL CHANGE AND DYSARTHRIA DIAGNOSED AS AN ISCHEMIC STROKE. THE PATIENT WAS TREATED WITH ANTI-COAGULATION THERAPY. THE SYMPTOMS LASTED 48 TO 72 HOURS, RECOVERY WAS PARTIAL WITH MINOR RESIDUAL EFFECTS. THE EVENT WAS CONFIRMED BY MRI THE NEXT DAY SUGGESTING AN EMBOLIC EVENT. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH ASPIRIN AND CLOPIDOGREL PRESCRIBED. THE PATIENTS MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA AND HYPERTENSION WITH HIGH RISK CRITERIA INCLUDING AGE > (B)(6). THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. 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 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. CEREBROVASCULAR ACCIDENT IS A WELL DOCUMENTED POTENTIAL COMPLICATION OF CAROTID ARTERY INTERVENTIONS AND IS LISTED IN THE IFU AS SUCH. 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. ABOUT 15 PERCENT OF EMBOLIC STROKES OCCUR IN PEOPLE WITH ATRIAL FIBRILLATION. WHEN A CLOT FORMS IN A BLOOD VESSEL IN THE BRAIN OR NECK IT IS CALLED A THROMBOTIC STROKE. EMBOLIC AND THROMBOTIC STROKES ARE CATEGORIZED AS ISCHEMIC STROKE. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, PHARMACEUTICAL, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) REGISTRY, THE PATIENT EXPERIENCED A STROKE THE SAME DAY AS THE INDEX PROCEDURE. THE PATIENT IS A (B)(6) MALE WHO WAS ENROLLED IN THE (B)(4) STUDY FOR STENTING OF THE CAROTID ARTERY. THE TARGET LESION LOCATION WAS THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS ECCENTRIC AND ULCERATED WITH MILD CALCIFICATION. THE RATE OF STENOSIS WAS 70%. AN ANGIOGUARD ((B)(4)/ LOT 70612471) EMBOLIC PROTECTION DEVICE WAS POSITIONED DISTAL TO THE LESION AND A PRECISE ((B)(4)/ LOT 15431688) STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION. THE FILTER WAS REMOVED FROM THE PATIENT AND UPON INSPECTION THERE WAS DEBRIS FOUND IN THE FILTER BASKET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ON THE NIGHT OF THE PROCEDURE (6-12 HOURS LATER) THE PATIENT SUFFERED AND ADVERSE EVENT DESCRIBED AS BEHAVIORAL CHANGE AND DYSARTHRIA. THE ONSET WAS GRADUAL; RECOVERY WAS PARTIAL WITH MINOR RESIDUAL EFFECTS. THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE. THE PATIENT WAS TREATED WITH ANTI-COAGULATION THERAPY, WHICH WAS SWITCHED FROM PLAVIX TO BRILINTA BECAUSE PLATELET FUNCTION STUDIES SHOWED THAT THE PATIENT WAS NOT RESPONSIVE TO PLAVIX. THE SYMPTOMS LASTED 48 TO 72 HOURS. THE EVENT WAS CONFIRMED WITH AN MRI THE NEXT DAY SUGGESTING AN EMBOLIC EVENT. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH ASPIRIN AND CLOPIDOGREL PRESCRIBED.

    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 15431688

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R ANGIOGUARD