BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE RX NITINOL STENT

    MDR report key: 2061343 · Received April 18, 2011

    Report

    Report Number
    9616099-2011-00257
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    October 4, 2007
    Report Date
    October 30, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K041796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS A (B)(6) WOMAN WITH A HISTORY OF TIA, CHF, CAD, MI, CABG SURGERY, PCI, ABNORMAL STRESS TEST, DYSLIPIDEMIA, DIABETES, HYPERTENSION, DEPRESSION, NEPHROLITHIASIS, OBESITY, GLAUCOMA AND CATARACTS. ON (B)(6) 2007, THE PRE-PROCEDURE NIH STROKE SCALE SCORE WAS 0 AND THE RANKIN STROKE SCALE SCORE WAS 0. ON (B)(6) 2007, AT 12:38 SHE UNDERWENT THE INDEX PROCEDURE FOR TREATMENT AN 80% STENOSIS IN THE IN THE BIFURCATION OF THE RIGHT CCA. THE TARGET LESION WAS DESCRIBED AS ECCENTRIC, ULCERATED WITH THROMBUS PRESENT WITHIN THE LESION. THE ANGIOGUARD WAS DELIVERED, THE LESION WAS PRE-DILATED AND ONE PRECISE STENT WAS SUCCESSFULLY DEPLOYED. THE ANGIOGUARD WAS RETRIEVED WITH DEBRIS NOTED IN THE FILTER. THE SITE REPORTED A 0% FINAL RESIDUAL IN-LESION STENOSIS. THE ADDITIONAL INFORMATION FORM REPORTED NO NEW NEUROLOGICAL DEFICITS DURING THE PROCEDURE; HOWEVER, THE PHYSICIAN REPORT DATED (B)(4) 2007 NOTED THAT THE PATIENT HAD BRIEF EPISODE OF LEFT SIDED ARM WEAKNESS WHEN HER BLOOD PRESSURE DROPPED SIGNIFICANTLY (SBP 80'S) DURING THE PROCEDURE; THIS WAS A ONE-TIME INCIDENT; HER ANGIOGRAM WAS REVIEWED AND THE PATIENT WAS NOTED TO HAVE RIGHT SIDED SUPRACLINOID STENOSIS OF APPROXIMATELY 75%. THE PROCEDURE ENDED AT 13:27. ON (B)(6) 2007, THE SITE REPORTED A GRADUAL ONSET OF NEW NEUROLOGICAL DEFICITS RECORDED IN THE NEUROLOGICAL EVENT FORM AS BEHAVIORAL CHANGE, DYSARTHRIA AND REFLEX CHANGE. ADJUDICATION HAS DETERMINED THESE EVENTS TO BE A TIA LASTING >24HOURS AND RELATED TO THE DEVICE AND THE PROCEDURE. THE ADJUDICATION DISAGREED THAT THE PATIENT EXPERIENCED A STROKE. A CT SCAN OF THE HEAD WITHOUT CONTRAST PERFORMED ON (B)(6) 2007 AT 17:05 REVEALED THE FOLLOWING: CHRONIC ISCHEMIA IN THE PERIVENTRICULAR WHITE MATTER; APICAL HYPODENSE AREA IN THE RIGHT BASAL GANGLIA MAY REPRESENT A FOCUS OF CHRONIC ISCHEMIA OR A SMALL LACUNAR INFARCT; THERE WERE NO HEMORRHAGE, INFARCT, MASS, HYDROCEPHALUS OR ANY EXTRAAXIAL FLUID COLLECTIONS. A NEUROLOGIST WAS CONSULTED ON (B)(6) 2007, THE NEUROLOGIST'S IMPRESSION WAS AS FOLLOWS: THIS MAY VERY WELL BE ALL DRUG-RELATED; NEED TO HOLD OFF ANY PSYCHOTROPIC'S AT THIS TIME; THE PATIENT WAS NOT SHOWING ANY MAJOR NEUROLOGICAL DEFICITS CONSISTENT WITH A STROKE. A CT SCAN OF THE HEAD WITHOUT CONTRAST PERFORMED ON (B)(6) 2007 REVEALED NO SIGNIFICANT CHANGES FROM PRIOR STUDY. A CT SCAN OF THE HEAD WITHOUT CONTRAST PERFORMED ON (B)(6) 2007 REVEALED NO SIGNIFICANT CHANGES FROM PRIOR STUDY. A CT SCAN OF THE HEAD WITH AND WITHOUT CONTRAST ON (B)(6) 2007 REVEALED NO EVIDENCE OF INTRACRANIAL HEMORRHAGE OR MASS EFFECT; CHRONIC WHITE MATTER ISCHEMIC CHANGES SIMILAR TO PRIOR STUDY DATED (B)(6) 2007, NO ENHANCING MASS WAS IDENTIFIED. A FOLLOW-UP CT SCAN OF THE HEAD WITH AND WITHOUT CONTRAST ON (B)(6) 2007 REVEALED NO ACUTE INTRACRANIAL PROCESS. AN EEG PERFORMED ON (B)(6) 2007 WAS ABNORMAL AND CONSISTENT WITH MODERATELY SEVERE ENCEPHALOPATHY; THIS COULD BE RESULT OF HYPOXIC ISCHEMIC CEREBRAL INJURY. THE SITE REPORTED THIS NEUROLOGICAL EVENT AS OTHER AND FURTHER NOTED THAT THE DEFICITS LASTED >24 HOURS BUT FULLY RESOLVING WITHOUT RESIDUAL DEFICITS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. 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 THE AMERICAN HEART ASSOCIATION AND AMERICAN STROKE ASSOCIATION (AHA/ASA), 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. 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. 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. 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) REGISTRY, THE PATIENT HAD HYPOTENSION DURING THE INDEX PROCEDURE AND EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA) THE FOLLOWING DAY POST INDEX PROCEDURE. THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND EXPIRED APPROXIMATELY ELEVEN MONTHS POST INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 80% STENOSIS OF THE RIGHT COMMON CAROTID BIFURCATION. THE LESION WAS DESCRIBED AS 20MM IN LENGTH, CONCENTRIC, MILDLY CALCIFIED, MILDLY TORTUOUS, ECCENTRIC, THROMBUS PRESENT AND ULCERATED. THE REFERENCE VESSEL WAS 6.0MM IN DIAMETER. THE PATIENT'S PRE-PROCEDURE NIH STROKE SCALE SCORE WAS 0. THE PATIENT WAS ASYMPTOMATIC. AN ANGIOGUARD WITH A 6MM BASKET WAS DEPLOYED BEYOND THE LESION AFTER BEING PRE-DILATED. A 9 X 30MM PRECISE RX STENT WAS IMPLANTED AT THE TARGET LESION, WITH 0% RESIDUAL STENOSIS. THE PHYSICIAN REPORT DATED (B)(4) 2007 NOTED THAT THE PATIENT HAD BRIEF EPISODE OF LEFT SIDED ARM WEAKNESS WHEN HER BLOOD PRESSURE DROPPED SIGNIFICANTLY (SBP 80'S) DURING THE PROCEDURE; THIS WAS A ONE-TIME INCIDENT; HER ANGIOGRAM WAS REVIEWED AND THE PATIENT WAS NOTED TO HAVE RIGHT SIDED SUPRACLINOID STENOSIS OF APPROXIMATELY 75%. THE PROCEDURE ENDED AT 13:27. DEBRIS WAS NOTED IN THE ANGIOGUARD. PRESENCE OF AIR BUBBLES WAS NOT NOTED. THE FOLLOWING DAY, POST INDEX PROCEDURE, THE PATIENT EXPERIENCED BEHAVIORAL CHANGE, DYSARTHRIA AND REFLEX CHANGE. THE ONSET WAS GRADUAL AND LASTED >24 HOURS. THE EVENT WAS DETERMINED TO BE A TIA PER ADJUDICATION MINUTES RECEIVED ON 03/30/2011. THE RECOVERY WAS FULL WITHOUT ANY DEFICIT. THE PATIENT WAS DISCHARGED SIXTEEN DAYS AFTER THE INDEX PROCEDURE WITH AN NIH STROKE SCALE OF 0. APPROXIMATELY ELEVEN MONTHS POST INDEX PROCEDURE THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE RX NITINOL STENT SELF EXPANDING STENTS (NIM) FGE CORDIS DE MEXICO NA 13199980

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| H| L