BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 3091388 · Received May 3, 2013

    Report

    Report Number
    1016427-2013-00052
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 9, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDENDUM: ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT A NON-CORDIS SHEATH WAS USED. COMPLAINT CONCLUSION: AS REPORTED VIA THE SAPPHIRE REGISTRY, A PATIENT EXPERIENCED A NEUROLOGICAL EVENT DURING THE INDEX PROCEDURE REQUIRING ADDITIONAL INTERVENTION. PRE-PROCEDURE NIH STROKE SCALE WAS 0, STROKE SCALE WAS 0 AND THE PATIENT WAS ASYMPTOMATIC. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 90% STENOSIS TO THE LEFT PROXIMAL INTERNAL CAROTID ARTERY. A NON-CORDIS SHEATH WAS USED. THE LESION WAS DESCRIBED AS 20MM IN LENGTH, ARCH TYPE II, ECCENTRIC AND MILDLY CALCIFIED. THE REFERENCE VESSEL WAS 7.0 IN DIAMETER AND MODERATELY TORTUOUS. A 7MM ANGIOGUARD WAS DEPLOYED SUCCESSFULLY BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED. A 7.0 X 30MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION. ANGIOGRAPHY SHOWED SLUGGISH FLOW AFTER STENT PLACEMENT, ASPIRATION DONE. PATIENT WAS UNABLE TO SQUEEZE TOY. CODE ONE CALLED. FILTER WAS REMOVED AND PATIENT¿S SYMPTOMS RESOLVED. CODE ONE WAS CANCELLED. IT IS UNKNOWN IF DEBRIS WAS NOT NOTED IN THE FILTER BASKET. IT WAS NOT DOCUMENTED IF AIR BUBBLES WERE PRESENT. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. THE EVENT WAS CLASSIFIED AS ¿OTHER¿ AND THE DURATION OF THE SYMPTOMS RESOLVED IN 2-3 MINUTES. HE WAS NOT MEDICALLY TREATED. HE DID NOT UNDERGO ANY DIAGNOSTIC PROCEDURES DUE TO THE EVENT. THE PATIENT HAD A FULL RECOVERY WITH NO RESIDUAL DEFICITS. THE POST NIH STROKE SCALE SCORE AND STROKE SCALE SCORE WERE NOT PROVIDED. PER THE INVESTIGATOR, THE EVENT WAS RELATED TO THE INDEX PROCEDURE AND NOT RELATED TO THE CORDIS STUDY DEVICE. THE PATIENT¿S MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA, CABG, MYOCARDIAL INFARCTION AND HYPERTENSION. HIGH RISK CRITERIA: RECENT MI (GREATER THAN 24HRS. AND LESS THAN 6WEEKS), AGE > (B)(6). (B)(4): THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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. HYPOPERFUSION AND THE RESULTANT TIA ARE WELL-KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. TIA SYMPTOMS ARE SIMILAR TO THOSE OF STROKE BUT DO NOT LAST AS LONG. TYPICALLY SYMPTOMS OF A TIA OFTEN LAST ONLY A FEW MINUTES, MOST SYMPTOMS RESOLVE WITHIN AN HOUR BUT THEY MAY LAST UP TO 24 HOURS. TIA OCCURS WHEN THE BLOOD SUPPLY TO PART OF THE BRAIN IS BRIEFLY INTERRUPTED. 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. MUSCLE WEAKNESS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANY INTERVENTIONAL PROCEDURE WHERE DEVICES ARE INTRODUCED INTO THE VASCULATURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. VOLUNTARY MUSCLE WEAKNESS, AS A SYMPTOM OF TIA, IS A WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. 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. THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(4) REGISTRY, A PATIENT EXPERIENCED A NEUROLOGICAL EVENT DURING THE INDEX PROCEDURE REQUIRING ADDITIONAL INTERVENTION. PRE-PROCEDURE NIH STROKE SCALE WAS 0, STROKE SCALE WAS 0 AND THE PATIENT WAS ASYMPTOMATIC. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 90% STENOSIS TO THE LEFT PROXIMAL INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS 20MM IN LENGTH, ARCH TYPE II, ECCENTRIC AND MILDLY CALCIFIED. THE REFERENCE VESSEL WAS 7.0 IN DIAMETER AND MODERATELY TORTUOUS. A 7MM ANGIOGUARD WAS DEPLOYED SUCCESSFULLY BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED. A 7.0 X 30MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION. ANGIOGRAPHY SHOWED SLUGGISH FLOW AFTER STENT PLACEMENT, ASPIRATION DONE. PATIENT WAS UNABLE TO SQUEEZE TOY. CODE ONE CALLED. FILTER WAS REMOVED AND PATIENT'S SYMPTOMS RESOLVED. CODE ONE WAS CANCELLED. IT IS UNKNOWN IF DEBRIS WAS NOT NOTED IN THE FILTER BASKET. IT WAS NOT DOCUMENTED IF AIR BUBBLES WERE PRESENT. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. THE EVENT WAS CLASSIFIED AS "OTHER" AND THE DURATION OF THE SYMPTOMS RESOLVED IN 2-3 MINUTES. HE WAS NOT MEDICALLY TREATED. HE DID NOT UNDERGO ANY DIAGNOSTIC PROCEDURES DUE TO THE EVENT. THE PATIENT HAD A FULL RECOVERY WITH NO RESIDUAL DEFICITS. THE POST NIH STROKE SCALE SCORE AND STROKE SCALE SCORE WERE NOT PROVIDED. PER THE INVESTIGATOR, THE EVENT WAS RELATED TO THE INDEX PROCEDURE AND NOT RELATED TO THE CORDIS STUDY DEVICE. THE PATIENT WAS DISCHARGED SEVEN DAYS AFTER THE INDEX PROCEDURE DUE TO OTHER MEDICAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194440 ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 71012438

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening| R