BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVIATOR PLUS PTA DILATATION CATHETER

    MDR report key: 2688393 · Received August 9, 2012

    Report

    Report Number
    9616099-2012-00410
    Event Type
    Injury
    Date Received
    August 9, 2012
    Date of Event
    July 12, 2012
    Report Date
    July 16, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K071189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF THREE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2012-00410, 1016427-2012-00105, AND 9616099-2012-00411.

    Additional Manufacturer Narrative · 1

    THE EMAIL RECEIVED FOR THE (B)(6) STUDY INDICATED THAT DURING INDEX PROCEDURE THE PATIENT EXPERIENCED AN ISCHEMIC STROKE. MRI AND MRA SHOW A WATERSHED INFARCT BEYOND JUST THE TERRITORY OF THE RIGHT ICA. THE PATIENT IS AN (B)(6) MALE WHO WAS ENROLLED IN THE (B)(6) STUDY FOR STENTING OF THE BIFURCATION OF THE RIGHT COMMON CAROTID ARTERY (R8) AND THE RIGHT INTERNAL CAROTID (RCA). THE VESSEL WAS DESCRIBED AS MODERATELY CALCIFIED AND SEVERELY TORTUOUS. THE RATE OF STENOSIS WAS 75%. IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE WAS ELEVATED (184/96) PRIOR TO THE PROCEDURE. AN ANGIOGUARD WAS DEPLOYED DISTAL TO THE LESION AND DUE TO SOME BLOOD PRESSURE RESPONSE JUST CROSSING THE LESION, THE LESION WAS DIRECTLY STENTED WITH A PRECISE STENT. THE HIGHEST PRESSURE WAS 214/124, NITRO WAS GIVEN PRIOR TO START OF PROCEDURE; IT WAS NOT RE-INITIATED DURING THIS TIME. THE STENT WAS POST DILATED WITH A 6.0MM AVIATOR PLUS BALLOON WITH 0% RESIDUAL STENOSIS AND NORMAL ANTEGRADE FLOW ESTABLISHED. DURING POST DILATION OF THE STENT THE PATIENT SUFFERED GRADUAL ONSET NEUROLOGICAL CHANGES DESCRIBED AS REFLEX CHANGE WITH HEMIPARESIS AND HEMINEGLECT OF THE LEFT SIDE. THE VESSEL DID HAVE SLOW FLOW NOTED AFTER-THE INTERVENTION AND ALMOST NO FLOW WAS NOTED ACROSS THE DISTAL PROTECTION DEVICE, WHICH WAS REMOVED AT THE-TIME. UPON REMOVAL IT WAS NOTICED THAT THERE WAS DEBRIS IN THE BASKET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. HYPOTENSION, HYPOPERFUSION AND STROKE ARE WELL-KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. THE HEMODYNAMIC INSTABILITY THAT OCCURS BOTH DURING AND AFTER CAROTID STENT IMPLANTATION IS INFLUENCED BY THE BARO-RECEPTORS, WHICH ARE LOCATED AT THE CAROTID BIFURCATION. THESE BARO-RECEPTORS ARE STIMULATED BY THE STRETCH OF INTERVENTIONAL BALLOONS, SDS (STENT DELIVERY SYSTEM) AND DISTAL PROTECTION DEVICES, INITIATING A REFLEX VIA THE GLOSSOPHARYNGEAL NERVE. THIS RESULTS IN A FALL IN BLOOD PRESSURE AND BRADYCARDIA. STENT PLACEMENT MAY PROMOTE PERSISTENT STIMULATION OF THESE BARO-RECEPTORS. THESE REACTIONS ARE ANTICIPATED RELATIVELY SHORT-TERM ADVERSE EVENTS ASSOCIATED WITH THE COMPRESSION OF THE BARO-RECEPTORS DURING BALLOON INFLATION, STENT IMPLANTATION AND FILTER DEVICE MANIPULATION. CERTAIN FACTORS MAY INFLUENCE THE LIKELIHOOD OF ANTICIPATED BARO-RECEPTOR REACTIONS SUCH AS ADVANCED AGE, VENTRICULAR DYSFUNCTION AND GENDER. 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. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF THREE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2012-00410, 1016427-2012-00105, AND 9616099-2012-00411.

    Description of Event or Problem · 1

    THE EMAIL RECEIVED FOR THE (B)(4) STUDY INDICATED THAT DURING INDEX PROCEDURE THE PATIENT EXPERIENCED AN ISCHEMIC STROKE. THE PATIENT IS AN (B)(6) MALE WHO WAS ENROLLED IN THE SAPPHIRE STUDY FOR STENTING OF THE RIGHT CAROTID ARTERY. THE TARGET LESION LOCATION WAS THE BIFURCATION OF THE RIGHT COMMON CAROTID ARTERY (R8) AND THE RIGHT INTERNAL CAROTID (RCA). THE VESSEL WAS DESCRIBED AS MODERATELY CALCIFIED AND SEVERELY TORTUOUS. THE RATE OF STENOSIS WAS 75%. IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE WAS ELEVATED (184/96) PRIOR TO THE PROCEDURE. AN ANGIOGUARD (601814RMC/ LOT 70911418) EMBOLIC PROTECTION DEVICE WAS DEPLOYED DISTAL TO THE LESION AND DUE TO SOME BLOOD PRESSURE RESPONSE JUST CROSSING THE LESION, THE LESION WAS DIRECTLY STENTED WITH A PRECISE (PC0930RXC/ LOT 15608509) STENT. THE HIGHEST PRESSURE WAS 214/124, NITRO WAS GIVEN PRIOR TO START OF PROCEDURE; IT WAS NOT RE-INITIATED DURING THIS TIME. THE STENT WAS POST DILATED WITH A 6.0MM AVIATOR PLUS BALLOON UP TO 13 ATMOSPHERES WITH 0% RESIDUAL STENOSIS AND NORMAL ANTEGRADE FLOW ESTABLISHED. DURING POST DILATION OF THE STENT THE PATIENT SUFFERED NEUROLOGICAL CHANGES DESCRIBED AS REFLEX CHANGE WITH HEMIPARESIS AND HEMINEGLECT OF THE LEFT SIDE. THE ONSET WAS GRADUAL. THE VESSEL DID HAVE SLOW FLOW NOTED AFTER-THE INTERVENTION AND ALMOST NO FLOW WAS NOTED ACROSS THE DISTAL PROTECTION DEVICE, WHICH WAS REMOVED AT THE-TIME. UPON REMOVAL, IT WAS NOTICED THAT THERE WAS DEBRIS IN THE BASKET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE. MRI AND MRA SHOW A WATERSHED INFARCT BEYOND JUST THE TERRITORY OF THE RIGHT ICA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVIATOR PLUS PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R ANGIOGUARD RX, PRECISE STENT