BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1905376 · Received November 23, 2010

    Report

    Report Number
    1016427-2010-00143
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 29, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A 4.5MM BALLOON WAS USED TO EXPAND THE OVERLAPPING STENTS. THE ANGIOGUARD WAS REMOVED AND NO DEBRIS WAS OBSERVED IN THE FILTER BASKET. DURING THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE A TRANSIENT PRESENTATION OF RIGHT FACIAL DROPPING AND MILD SLURRING OF HIS SPEECH. THE EPISODES WERE TRANSIENT AND FOLLOWED INITIAL STENT PLACEMENT. THE ISCHEMIC SYMPTOMS RESOLVED FOLLOWING PLACEMENT OF THE SECOND STENT. THIS EPISODE WAS DIAGNOSED AS A TIA. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH AN (B)(4) STROKE SCALE SCORE OF 1 AND RANKIN SCORE OF 0. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00887, 1016427-2010-00143 AND 9616099-2010-00888.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED VIA THE SAPPHIRE REGISTRY, A PATIENT EXPERIENCED A VESSEL DISSECTION AND A TRANSIENT ISCHEMIC ATTACK (TIA) DURING THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 80% TO 99% STENOSIS IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS 8.23MM IN LENGTH, SEVERELY CALCIFIED, ECCENTRIC, AND ULCERATED, WITH THROMBUS PRESENT WITHIN THE LESION. THE LESION WAS A RESTENOSIS OF A PREVIOUS CAROTID ENDARTERECTOMY. THE REFERENCE VESSEL WAS 3.8MM IN DIAMETER AND MILDLY TORTUOUS. THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE PROCEDURE WITH BASELINE NIH STROKE SCALE SCORE OF 2 AND RANKIN SCORE OF 0. A 4MM ANGIOGUARD RX WAS DEPLOYED BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED. A 7.0 X 30MM PRECISE PRO RX WAS IMPLANTED WITHIN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY, EXTENDING DISTALLY INTO THE COMMON CAROTID ARTERY. REPEAT ANGIOGRAPHY REVEALED DECREASED FLOW VELOCITY IN THE LEFT INTERNAL CAROTID ARTERY AND AN OCCULT DISSECTION OR OTHER FLOW-LIMITING ABNORMALITY WAS SUSPECTED. A 6.0 X 30MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION TO STABILIZE THE VESSEL DISSECTION. THE DECREASED FLOW VELOCITY WAS PERSISTENT, BUT HAD IMPROVED FROM THE PREVIOUS STENT PLACEMENT. A 4.5MM BALLOON WAS USED TO EXPAND THE OVERLAPPING STENTS. THE ANGIOGUARD WAS REMOVED AND NO DEBRIS WAS OBSERVED IN THE FILTER BASKET. DURING THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE A TRANSIENT PRESENTATION OF RIGHT FACIAL DROPPING AND MILD SLURRING OF HIS SPEECH. THE EPISODES WERE TRANSIENT AND FOLLOWED INITIAL STENT PLACEMENT. THE ISCHEMIC SYMPTOMS RESOLVED FOLLOWING PLACEMENT OF THE SECOND STENT. THIS EPISODE WAS DIAGNOSED AS A TIA. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH AN NIH STROKE SCALE SCORE OF 1 AND RANKIN SCORE OF 0. THE PATIENT'S MEDICAL HISTORY INCLUDES STROKE, SEVERE PULMONARY DISEASE, HYPERLIPIDEMIA, ABNORMAL STRESS TEST, PAST HISTORY OF SMOKING, DIABETES MELLITUS, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, CORONARY PERCUTANEOUS REVASCULARIZATION, RIGHT COMMON ILIAC ARTERY STENT PLACEMENT PREVIOUS RIGHT CAROTID ENDARTERECTOMY (1997) AND HYPERTENSION. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. HYPOTENSION, HYPOPERFUSION AND THE RESULTANT TIA ARE WELL-KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. TIA WAS ORIGINALLY DEFINED AS A SUDDEN ONSET OF A FOCAL NEUROLOGIC SYMPTOM AND/OR SIGN LASTING LESS THAN 24 HOURS, PRESUMABLY BROUGHT ON BY A TRANSIENT DECREASE IN BLOOD SUPPLY, WHICH RENDERED THE BRAIN ISCHEMIC IN THE AREA PRODUCING THE SYMPTOM. HOWEVER, THIS CLASSIC DEFINITION OF TIA WAS INADEQUATE FOR SEVERAL REASONS. AS ENDORSED BY 2009 GUIDELINES FROM (B)(6), TRANSIENT ISCHEMIC ATTACK (TIA) IS NOW DEFINED AS A TRANSIENT EPISODE OF NEUROLOGIC DYSFUNCTION CAUSED BY FOCAL BRAIN, SPINAL CORD, OR RETINAL ISCHEMIA, WITHOUT ACUTE INFARCTION. ISCHEMIC STROKE IS NOW DEFINED AS AN INFRACTION OF CENTRAL NERVOUS SYSTEM TISSUE. 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. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. VESSELS THAT ARE RESISTANT TO ANGIOPLASTY HAVE A HIGHER RISK OF INTIMAL DISSECTION DURING INTERVENTIONAL PROCEDURES. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. IN VIEW OF THE PLANNED STENT PROCEDURE, THE DISSECTION OCCURRING WITH PREDILATATION WAS APPROPRIATELY TREATED WITH THE PLANNED STENT IMPLANTATION. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. THIS DOES NOT REPRESENT DEVICE MALFUNCTION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT VESSEL / LESION CHARACTERISTICS AND POSSIBLY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. 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. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE ROOT CAUSE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00887, 1016427-2010-00143 AND 9616099-2010-00888.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(6) REGISTRY, A PATIENT EXPERIENCED A VESSEL DISSECTION AND A TRANSIENT ISCHEMIC ATTACK (TIA) DURING THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE ANGIOGRAPHY REVEALED 80% TO 99% STENOSIS IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS 8.23MM IN LENGTH, SEVERELY CALCIFIED, ECCENTRIC, AND ULCERATED, WITH THROMBUS PRESENT WITHIN THE LESION. THE LESION WAS A RESTENOSIS OF A PREVIOUS CAROTID ENDARTERECTOMY. THE REFERENCE VESSEL WAS 3.8MM IN DIAMETER AND MILDLY TORTUOUS. THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE PROCEDURE WITH BASELINE (B)(4) STROKE SCALE SCORE OF 2 AND RANKIN SCORE OF 0. A 4MM ANGIOGUARD RX WAS DEPLOYED BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED. A 7.0 X 30MM PRECISE PRO RX WAS IMPLANTED WITHIN THE PROXIMAL LEFT INTERNAL CAROTID, EXTENDING INTO THE COMMON CAROTID ARTERY DISTALLY. REPEAT ANGIOGRAPHY REVEALED DECREASED FLOW VELOCITY IN THE LEFT INTERNAL CAROTID ARTERY AND AN OCCULT DISSECTION OR OTHER FLOW-LIMITING ABNORMALITY WAS SUSPECTED. A 6.0 X 30MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION TO STABILIZE THE VESSEL DISSECTION. THE DECREASED FLOW VELOCITY WAS PERSISTENT, BUT HAD IMPROVED FROM THE PREVIOUS STENT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION 70909502

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 7X30MM AND 6X30 PRECISE PRO RX