BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE SDS SELF EXPANDING

    MDR report key: 2843052 · Received November 21, 2012

    Report

    Report Number
    9616099-2012-00694
    Event Type
    Death
    Date Received
    November 21, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 31, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K012993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE REPORTED EVENTS ARE FROM A LITERATURE ARTICLE. SPECIFIC PATIENT AND PROCEDURAL DETAILS ARE NOT AVAILABLE. THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE. THE DETAILS ARE IKARI ET AL INITIAL RESULTS OF CAROTID ARTERY STENTING IN JAPAN; CARDIOVASC INTERV AND THER 1298-012-0134. PLEASE NOTE THAT THIS REPORT REPRESENTS NOTIFICATION OF 21 DEATHS OR PERIPROCEDURAL STROKES AS INDICATED IN THE REFERENCED ARTICLE. THIS IS ONE OF 10 PRODUCTS INVOLVED WITH THE REPORTED EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 1016427-2012-00145, 9616099-2012-00687, 9616099-2012-00688, 9616099-2012-00689, 9616099-2012-00690, 9616099-2012-00691, 9616099-2012-00692, 9616099-2012-00693, 9616099-2012-00694 AND 9616099-2012-00695.

    Additional Manufacturer Narrative · 1

    IKARI ET AL INITIAL RESULTS OF CAROTID ARTERY STENTING IN (B)(6); CARDIOVASC INTERV AND THER 1298-012-0134; REPORT FINDINGS OF THE (B)(4) STUDY INVOLVING 704 PATIENTS USING THE ANGIOGUARD DISTAL PROTECTION DEVICE AND THE PRECISE STENT. IN 3 CASES THE ANGIOGUARD DID NOT CROSS AND A PERCUSURGE PROTECTION BALLOON WAS USED IN 2 AND NO PROTECTION IN 1. THERE WERE ALSO 65 CASES OF FILTER SLOW, NO REFLOW DURING THE PROCEDURE. AT THE 30 DAY FOLLOW-UP, THERE WERE 2 DEATHS, 24 STROKES (3 MAJOR IPSILATERAL, 1 MAJOR NON IPSILATERAL, 17 MINOR IPSILATERAL AND 3 MINOR NON IPSILATERAL). IN ADDITION, THERE WERE 15 CASES OF TIA, 1 CASE OF STENT THROMBOSIS, 4 CASES OF MAJOR BLEEDING, 74 CASES OF SEVERE HYPOTENSION, 72 CASES OF BRADYCARDIA, 1 CASE OF HYPERPERFUSION SYNDROME. THERE WERE 65 REPORTED EVENTS OF SLOW FLOW/NO FLOW FOR THE ANGIOGUARD. THERE IS NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS STERILE LOT NUMBERS WERE NOT AVAILABLE, DEVICE HISTORY RECORD REVIEWS COULD NOT BE PERFORMED. NUMEROUS REPORTS HAVE SUBSEQUENTLY DOCUMENTED THE RISK OF HYPERPERFUSION SYNDROME AFTER CAROTID ENDARTERECTOMY, AFTER CAROTID ANGIOPLASTY AND AFTER INTRACRANIAL ANGIOPLASTY. ESTIMATES OF THE INCIDENCE OF HYPERPERFUSION SYNDROME AFTER CAROTID REVASCULARIZATION RANGE UP TO (B)(4). AFTER REVASCULARIZATION THAT ALLEVIATES A HIGH-GRADE SYMPTOMATIC STENOTIC LESION, CEREBRAL HYPERPERFUSION SYNDROME (CHS) MAY OCCUR AS A RESULT OF A SUDDEN, RAPID INCREASE IN CEREBRAL BLOOD FLOW EXCESS OF THAT REQUIRED TO MEET METABOLIC DEMANDS. THERE ARE VARIOUS FACTORS IMPLICATED AS PLAYING A ROLE IN CHS, SUCH AS CEREBRAL AUTOREGULATION, HYPERTENSION, ISCHEMIA REPERFUSION INJURY, INTRAOPERATIVE ISCHEMIA, OXYGEN DERIVED FREE RADICALS AND BARORECEPTOR DYSFUNCTION. TRANSIENT CEREBRAL HYPEREMIA CAN LEAD TO SEVERE UNILATERAL HEADACHE, FACE AND EYE PAIN, CONFUSION, SEIZURES, FOCAL NEUROLOGIC DEFICITS, AND INTRACEREBRAL HEMORRHAGES. 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 3 WEEKS AFTER REVASCULARIZATION. ANTICOAGULATION IS A KNOWN RISK FACTOR FOR BRAIN HEMORRHAGE IN PATIENTS WITH PRE-EXISTING DISEASE. EVIDENCE FROM OBSERVATIONAL STUDIES, IN LACK OF 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 IN IPSILATERAL PEAK MIDDLE CEREBRAL ARTERY FLOW VELOCITY IN ADDITION TO PRE- AND POSTOPERATIVE HYPERTENSION. CEREBRAL HYPERPERFUSION SYNDROME (CHS) IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CAROTID STENTS. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. BLEEDING IS A POTENTIAL COMPLICATION OF ANY INTERVENTIONAL PROCEDURE WHERE FOREIGN OBJECTS ARE INTRODUCED INTO THE PATIENTS VASCULATURE. AT THIS TIME IT IS UNKNOWN WHERE THE BLEEDING OCCURRED AND WHAT THE OUTCOMES WERE. THEY MAY HAVE BEEN RELATED TO THE HYPERPERFUSION, ACCESS SITE COMPLICATIONS OR OTHER. THE FUNCTION OF AN EMBOLIC PROTECTION DEVICE IS TO CAPTURE DEBRIS DURING THE CAROTID PROCEDURE AND PREVENT IT FROM EMBOLIZING DOWNSTREAM INTO THE PATIENTS VASCULATURE. IF ENOUGH DEBRIS IS DISLODGED FROM THE ARTERIAL WALL DURING THE PROCEDURE IT MAY FILL THE FILTER BASKET TO THE POINT AT WHICH IT INTERFERES WITH NORMAL BLOOD FLOW THROUGH THE FILTER RESULTING IN HYPOPERFUSION. THIS IS AN INHERENT RISK OF THE PROCEDURE AND DOES NOT REPRESENT A DEVICE MALFUNCTION. NORMAL BLOOD FLOW RESUMES UPON REMOVAL OF THE DEVICE OR REMOVAL OF THE DEBRIS IN THE FILTER BY MEANS OF AN ASPIRATION CATHETER. HYPOTENSION, 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. VESSEL SPASM 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. APHASIA, 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. HEMODYNAMIC DEPRESSION DURING CAROTID ARTERY STENTING PROCEDURES IS A COMMON EVENT AND IS MOST LIKELY RELATED TO CORONARY SINUS REFLEX OR VAGAL RESPONSE. THE VAGUS NERVE ENTERS THE THORAX BETWEEN COMMON CAROTID ARTERY AND SUBCLAVIAN ARTERY AND DESCENDS DOWNWARD. DURING BALLOON INFLATION OR STENT DEPLOYMENT, PRESSURE CAN BE EXERTED ON THE NERVE STIMULATING A PARASYMPATHETIC RESPONSE, I.E. BRADYCARDIA, HYPOTENSION, HEART BLOCK, ASYSTOLE, ETC. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT IS RELATED TO A MANUFACTURING ISSUE OR DEFECT OF THE DEVICE, BUT IS LIKELY RELATED TO VESSEL CHARACTERISTICS, PATIENT AND PROCEDURAL FACTORS. THE FUNCTION OF AN EMBOLIC PROTECTION DEVICE IS TO CAPTURE DEBRIS DURING THE CAROTID PROCEDURE AND PREVENT IT FROM EMBOLIZING DOWNSTREAM INTO THE PATIENTS VASCULATURE. IF ENOUGH DEBRIS IS DISLODGED FROM THE ARTERIAL WALL DURING THE PROCEDURE IT MAY FILL THE FILTER BASKET TO THE POINT AT WHICH IT INTERFERES WITH NORMAL BLOOD FLOW THROUGH THE FILTER RESULTING IN HYPOPERFUSION. NORMAL BLOOD FLOW RESUMES UPON REMOVAL OF THE DEVICE OR REMOVAL OF THE DEBRIS IN THE FILTER BY MEANS OF AN ASPIRATION CATHETER. THIS IS AN INHERENT RISK OF THE PROCEDURE AND DOES NOT REPRESENT A DEVICE MALFUNCTION. CEREBROVASCULAR ACCIDENT IS A WELL DOCUMENTED POTENTIAL COMPLICATION OF CAROTID ARTERY INTERVENTIONS AND IS LISTED IN THE IFU AS SUCH. EMBOLIC STROKES ARE USUALLY CAUSED BY AN EMBOLUS (A BLOOD CLOT THAT FORMS ELSEWHERE IN THE BODY AND TRAVELS THROUGH THE BLOODSTREAM TO THE BRAIN) THAT TRAVELS FROM OTHER PARTS OF THE BODY TO THE NECK OR BRAIN AND BLOCKS A BLOOD VESSEL. EMBOLIC STROKES OFTEN RESULT FROM HEART DISEASE OR HEART SURGERY AND OCCUR RAPIDLY AND WITHOUT ANY WARNING SIGNS. ABOUT 15 PERCENT OF EMBOLIC STROKES OCCUR IN PEOPLE WITH ATRIAL FIBRILLATION. WHEN A CLOT FORMS IN A BLOOD VESSEL IN THE BRAIN OR NECK IT IS CALLED A THROMBOTIC STROKE. EMBOLIC AND THROMBOTIC STROKES ARE CATEGORIZED AS ISCHEMIC STROKE. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, PHARMACEUTICAL, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AROUND THE DAMAGED AREAS. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, PHARMACEUTICAL, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THIS IS ONE OF 10 PRODUCTS INVOLVED WITH THE REPORTED EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 1016427-2012-00145, 9616099-2012-00687, 9616099-2012-00688, 9616099-2012-00689, 9616099-2012-00690, 9616099-2012-00691, 9616099-2012-00692, 9616099-2012-00693, 9616099-2012-00694 AND 9616099-2012-00695.

    Description of Event or Problem · 1

    IKARI ET AL INITIAL RESULTS OF CAROTID ARTERY STENTING IN JAPAN; CARDIOVASC INTERV AND THER 1298-012-0134; REPORT FINDINGS OF THE CASCARD RETROSPECTIVE STUDY INVOLVING 704 PATIENTS USING THE ANGIOGUARD DISTAL PROTECTION DEVICE AND THE PRECISE STENT. IN 3 CASES THE ANGIOGUARD DID NOT CROSS AND A PERCUSURGE PROTECTION BALLOON WAS USED IN 2 AND NO PROTECTION IN 1. THERE WERE ALSO 65 CASES OF FILTER SLOW, NO REFLOW DURING THE PROCEDURE. AT THE 30 DAY FOLLOW-UP, THERE WERE 2 DEATHS, 24 STROKES (3 MAJOR IPSILATERAL, 4 MAJOR NON IPSILATERAL, 17 MINOR IPSILATERAL AND 3 MINOR NON IPSILATERAL. IN ADDITION, THERE WERE 15 CASES OF TIA, 1 CASE OF STENT THROMBOSIS, 4 CASES OF MAJOR BLEEDING, 74 CASES OF SEVERE HYPOTENSION, 72 CASES OF BRADYCARDIA, 7 CASES IF HYPERPERFUSION SYNDROME (6 CASES WERE SUSPECTED) AND DEATHS OR PERIPROCEDURAL STROKES 21 AND DEATH OR ANY STROKES 26.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE SDS SELF EXPANDING SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1