BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1021185 · Received March 28, 2008

    Report

    Report Number
    9616099-2008-00815
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 10, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A 4X20 MAVERICK BALLOON WAS INSERTED FOR PRE-DILATION AND INFLATED TWICE FOR A TOTAL OF 31 SECONDS AT 10 ATMOSPHERES. THE BALLOON CATHETER WAS REMOVED AND AN 8 X 30 PRECISE STENT WAS ADVANCED AND DEPLOYED IN THE LESION. THE STENT WAS THEN POST-DILATED WITH A 5.5X20 AVIATOR BALLOON. THE BALLOON WAS REMOVED AND A POST-ANGIOGRAM WAS PERFORMED. THE PHYSICIAN THEN INSERTED A 4FR, 135CM FETCH CATHETER INTO THE LEFT CAROTID FOR ASPIRATION OF THROMBUS IN THE FILTER. AT THIS POINT, IT WAS NOTED THAT THE PT BECAME DYSARTHRIC. THE ASPIRATION CATHETER WAS REMOVED AND THE ANGIOGUARD WERE REMOVED, BUT THE PT WAS STILL DYSARTHRIC, ALTHOUGH ABLE TO FOLLOW COMMANDS. LOPRESSOR WAS GIVEN FOR BLOOD PRESSURE CONTROL. POST-ANGIOGRAPHY WAS PERFORMED OF THE LEFT ICA. THE SHUTTLE SHEATH WAS REMOVED OVER A WIRE AND EXCHANGED FOR A 7FR SHEATH. THE PT'S SPEECH BY THIS TIME HAD RETURNED TO BASELINE. POST NEUROLOGIC EXAM BY THE PHYSICIAN SHOWED THAT THE PT HAD RETURNED TO BASELINE. THE SYMPTOMS FULLY RESOLVED WITHIN 24. THE PT WAS DISCHARGED IN 2008, WITH CLOPIDOGREL AND ASPIRIN DIRECTED. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADD'L INFO TO BE SUBMITTED 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG REPORT # 1016427-2008-00091.

    Description of Event or Problem · 1

    AFTER POST-DILATION OF THE STENT, THE PHYSICIAN USED AN ASPIRATION CATHETER TO REMOVE THROMBUS FROM THE LESION. WHEN PERFORMING THIS PROCEDURE, THE PT SUFFERED A NEUROLOGICAL DEFICIT OF DYSARTHRIA AND WAS DIAGNOSED WITH A TRANSIENT ISCHEMIC ATTACK (TIA). THE ONSET WAS SUDDEN AND RECOVERY WAS FULL. THE DURATION OF THE EVENT LASTED LESS THAN 24 HOURS. A MALE PT WAS CONSENTED TO THE STUDY IN 2008. THE INDEX PROCEDURE WAS COMPLETED ON THE SAME DAY, AND PT WAS SYMPTOMATIC. THE TARGET LESION LOCATION WAS THE PROXIMAL LEFT INTERNAL CAROTID ARTERY. THERE WAS NO OCCLUSION IN THE CONTRALATERAL CAROTID. REFERENCE VESSEL DIAMETER WAS 5MM. TARGET LESION DIAMETER STENOSIS WAS 99% WITH LESION LENGTH 20MM. TOTAL LENGTH OF STENTED SEGMENT WAS 30MM. QUALITATIVE LESION CALCIFICATION WAS DESCRIBED AS MILD. VESSEL TORTUOSITY BY VISUAL INSPECTION WAS MILD. AFTER PERFORMING DIAGNOSTIC AND SELECTIVE ANGIOGRAPHY OF THE AORTA AND CAROTID ARTERIES INTERVENTION OF THE LEFT CAROTID ARTERY WAS STARTED. THE PHYSICIAN MADE ACCESS IN THE RIGHT GROIN. A .035 STIFF ANGLED GLIDEWIRE WAS INSERTED AND A BERN CATHETER WAS ADVANCED AND INSERTED INTO THE LEFT EXTERNAL CAROTID ARTERY. THE GUIDEWIRE WAS REMOVED AND AN AMPLATZ WIRE WAS INSERTED. THE BERN CATHETER WAS REMOVED AND 7FR SHUTTLE SHEATH WAS INSERTED INTO THE CAROTID. A 6FR ANGIOGUARD WAS ADVANCED INTO THE LEFT INTERNAL CAROTID ARTERY (ICA) BEYOND THE LESION AND DEPLOYED. ACT WAS MEASURED AT 338 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENS (NIM) NIM CORDIS DE MEXICO NA 13303889

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R 4X20 MAVERICK BALLOON| 035 STIFF ANGLED GLIDEWIRE| 7FR. SHUTTLE SHEATH| ASPIRATION CATHETER| BERN CATHETER| 5.5X20 AVIATOR BALLOON