BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1193959 · Received October 8, 2008

    Report

    Report Number
    1016427-2008-00255
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    July 14, 2008
    Report Date
    September 16, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORDIS CORP REPORTED NO PRODUCT WOULD BE RETURNED TO FACILITY, FOR EVAL; HOWEVER, A COPY OF THE INVESTIGATION REQUEST INCLUDING LOT TRACEABILITY WAS PROVIDED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVAL, FACILITY, IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. FACLILTY, DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01997343. THIS PACKAGING LOT CONTAINED 99 UNITS, WHICH WERE SHIPPED FROM FACILITY, IN, 2008. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT FACILITY, AND WAS DETERMINED TO BE ACCEPTABLE. HYPOPERFUSION, CEREBRAL HYPERPERFUSION AND HYPOTENSION ARE ALL KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. IT IS NOTED THAT IN FOREIGN USAGE, DURING COMMON STENT PLACEMENT, VASCULAR SURGEONS HABITUALLY PERFORM IMPLANTATION ASPIRATION TECHNIQUES. THE PHYSICIAN WANTS TO AVOID HAVING UNCAUGHT DEBRIS IN CEREBRAL PERFUSION MOVE UPSTREAM, CAUSING CEREBRAL INFRACTION. THEY TAKE ADVANTAGE OF THE BLOCKAGE FUNCTION OF THE FILTER TO AVOID THIS EVENT AND SUCTION THE DEBRIS OUT OF THE FILTER. THE IFU STATES, "IF THE DISTAL PERFUSION OF DYE IS SIGNIFICANTLY REDUCED OR NO DYE IS PERFUSING PAST THE FILTER BASKET OR GUIDEWIRE DISTAL MARKER BAND, THE ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE MAY HAVE REACHED ITS CAPACITY TO CONTAIN EMBOLI. IF THERE IS A SEVERE REDUCTION IN DISTAL DYE PERFUSION, IT IS RECOMMENDED TO EXCHANGE THE ANGIOGUARD RX EMBOLI CAPTURE GUIDE WIRE FOR A NEW ONE." USAGE OF THE PRODUCT OTHER THAN THAT INDICATED IN THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) MAY INVOLVE ADD'L RISKS NOT DESCRIBED IN THE LABELING. NUMEROUS REPORTS HAVE DOCUMENTED THE RISK OF HYPERPERFUSION SYNDROME AFTER CAROTID ENDARTERECTOMY, CAROTID ANGIOPLASTY AND INTRACRANIAL ANGIOPLASTY. ESTIMATES OF THE INCIDENCE OF HYPERPERFUSION SYNDROME AFTER CAROTID REVASCULARIZATION RANGE UP TO 3%. TYPICALLY, INTRACEREBRAL HEMORRHAGE DEVELOPS ON THE THIRD TO FIFTH POSTOPERATIVE DAY, THOUGH THERE HAVE BEEN CASES OBSERVED IMMEDIATELY AFTER SURGERY, AS WELL AS CASES DEVELOPED AS LATE AS 3 WEEKS AFTER REVASCULARIZATION. EVIDENCE FROM OBSERVATIONAL STUDIES, IN LACK IN RANDOMIZED TRIALS, SUGGESTS THAT A NUMBER OF FACTORS-ALL REFERABLE TO HEMODYNAMIC EXHAUSTION OF THE CEREBRAL CIRCULATION-PLAY A ROLE, SUCH AS RECENT STROKE, SURGERY FOR VERY TIGHT INTERNAL CAROTID ARTERY STENOSIS, CONCOMITANT CONTRALATERAL TIGHT LESION, IMPAIRED CEREBROVASCULAR RESERVE (CEREBRAL HYPOPERFUSION), AND MARKED POSTOPERATIVE INCREASE OF AN IPSILATERAL PEAK MIDDLE CEREBRAL ARTERY FLOW VELOCITY IN ADDITION TO PRE AND POSTOPERATIVE HYPERTENSION. HYPOTENSION CAN BE ATTRIBUTED TO THE BARO-RECEPTOR TRAUMA THAT IS INTRINSIC TO THE CAROTID ARTERY MANIPULATION DURING STENT IMPLANTATION, AND IN THIS CASE TO THE ANTIHYPERTENSIVE MEDICATION USED TO TREAT THE CEREBRAL HYPERPERFUSION SYNDROME. THESE REACTIONS ARE ANTICIPATED SHORT-TERM ADVERSE EVENTS ASSOCIATED WITH THE COMPRESSION OF THE PRESSURE SENSITIVE RECEPTORS, LOCATED WITHIN THE CAROTID ARTERY STRUCTURE, DURING BALLOON INFLATION, STENT IMPLANTATION AND FILTER DEVICE MANIPULATION. REVIEW OF THE INFO SUGGESTS THAT PT, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS PRODUCT MALFUNCTION, WHICH IS ASSOCIATED WITH MFG REPORT #9616099-2008-02402.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVED STATES THAT DURING A CAROTID STENT IMPLANTATION PROCEDURE, THE PT EXPERIENCED HYPOPERFUSION AND AFTER THE PROCEDURE EXPERIENCED CEREBRAL HYPERPERFUSION SYNDROME AND HYPOTENSION. THIS IS A MALE WITH MEDICAL HISTORY INCLUDING DIABETES, TIA AND PCI (PERCUTANEOUS CORONARY INTERVENTION). THE TARGET LESION WAS RIGHT INTERNAL CAROTID ARTERY DESCRIBED AS MODERATELY CALCIFIED, NON-TORTUOUS WITH 95% STENOSIS. AN ANGIOGUARD WAS INSERTED, TRACKED, DEPLOYED AND RETRIEVED WITHOUT DIFFICULTIES. ONE PRECISE STENT WAS DEPLOYED WITHOUT REPORTED DIFFICULTIES. DURING THE PROCEDURE, THERE WAS HYPOPERFUSION THROUGH THE ANGIOGUARD, THE PHYSICIAN NOTED IT WAS PROBABLY DUE TO AN EXCESS OF DEBRIS FROM THE TARGET LESION. ASPIRATION TECHNIQUE WAS USED AND THE BLOOD FLOW RETURNED TO BASELINE. THE PT LEFT THE ANGIO SITE NEUROLOGICALLY INTACT. ONE HOUR POST PROCEDURE, THE PT COMPLAINED OF HEADACHE WITH VOMITING, DIAGNOSED AS CEREBRAL HYPERPERFUSION. THE HYPERPERFUSION SYNDROME WAS TREATED WITH ANTIHYPERTENSIVE MEDICATIONS FOR SYMPTOM CONTROL. THREE HOURS AFTER THE PROCEDURE, THE PT EXPERIENCED HYPOTENSION, THIS WAS MEDICALLY TREATED WITH VASOPRESSOR WITH RETURN TO BASELINE OF THE VITAL SIGNS. THERE IS NO REPORT OF FURTHER INJURY TO THE PT. THE ANGIOGUARD WAS DISCARDED AND THE STENT REMAINS IMPLANTED THUS BOTH DEVICES ARE UNAVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70308504

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention ASPIRATION CATHETER: ELIMINATE/CLINICAL SUPPLY