BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2714742 · Received August 27, 2012

    Report

    Report Number
    9616099-2012-00463
    Event Type
    Injury
    Date Received
    August 27, 2012
    Date of Event
    November 18, 2009
    Report Date
    November 24, 2009
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED AS AN ISCHEMIC STROKE. THE PATIENT WAS DISCHARGED 2 DAYS LATER ON ASA AND CLOPIDOGREL. AT THE 30 DAY FOLLOW-UP, THE NIH STROKE SCALE SCORE WAS 0 AND THE RANKIN STROKE SCALE SCORE WAS 0. CONCOMITANT DEVICES: 5 MM MEDIUM SUPPORT AND 7MM ANGIOGUARD DEVICES. CONCOMITANT MEDICATIONS: HEPARIN WAS GIVEN DURING THE PROCEDURE. PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS (B)(6) MALE PATIENT WITH A HISTORY OF HYPERLIPIDEMIA, CARDIAC ARRHYTHMIA, CHF, SMOKING, HYPERTENSION, CORONARY ARTERY DISEASE, AND PREVIOUS CABG WAS ADMITTED FOR CAROTID ARTERY STENTING. THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF TREATMENT. ANGIOGRAPHY REVEALED AN 85%, 21MM STENOSIS IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY. AN 8.0 X 30MM PRECISE STENT WAS IMPLANTED WITHOUT COMPLICATION. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY IN STABLE CONDITION WITH A STROKE SCALE SCORE OF 0. ASPIRIN AND PLAVIX WERE PRESCRIBED FOR ANTIPLATELET THERAPY. THE FOLLOWING DAY (2 DAYS POST INDEX PROCEDURE) THE PATIENT EXPERIENCED A SUDDEN ONSET OF DYSARTHRIA. THERE WAS NO EVIDENCE OF HEMIPARESIS, HEMITAXIA, OR HEMINEGLECT. THE PATIENT WAS DIAGNOSED WITH A STROKE SECONDARY TO INTRACRANIAL BLEEDING (INTRACEREBRAL/SUBARACHNOID HEMORRHAGE). THE APTT WAS 80 SECONDS AND THE ACT WAS 149. THE PATIENT'S SYMPTOMS SUBSIDED WITHOUT REQUIRING ANY ADDITIONAL TREATMENT. PER THE STUDY COORDINATOR, THE PATIENT'S STROKE WAS NOT RELATED TO HYPERPERFUSION SYNDROME. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15019648 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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. INTRACEREBRAL HEMORRHAGE USUALLY RESULTS FROM RUPTURE OF AN ARTERIOSCLEROTIC SMALL ARTERY THAT HAS BEEN WEAKENED, PRIMARILY BY CHRONIC ARTERIAL HYPERTENSION. SUCH HEMORRHAGES ARE USUALLY LARGE, SINGLE, AND CATASTROPHIC. IN SOME OLDER PEOPLE, AN ABNORMAL PROTEIN CALLED AMYLOID ACCUMULATES IN ARTERIES OF THE BRAIN. THIS ACCUMULATION (CALLED AMYLOID ANGIOPATHY) WEAKENS THE ARTERIES AND CAN CAUSE HEMORRHAGE. LESS COMMON CAUSES INCLUDE BLOOD VESSEL ABNORMALITIES PRESENT AT BIRTH, INJURIES, TUMORS, INFLAMMATION OF BLOOD VESSELS (VASCULITIS), BLEEDING DISORDERS, AND USE OF ANTICOAGULANTS IN DOSES THAT ARE TOO HIGH. BLEEDING DISORDERS AND USE OF ANTICOAGULANTS INCREASE THE RISK OF DYING FROM AN INTRACEREBRAL HEMORRHAGE. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE.

    Description of Event or Problem · 1

    AS IT WAS REPORTED BY THE (B)(4) STUDY, THE PATIENT SUFFERED A HEMORRHAGIC STROKE TWO DAYS POST PROCEDURE. PTA WAS PERFORMED ON AN 85% OCCLUDED LESION IN THE PROXIMAL INTERNAL CAROTID ARTERY OF 21.11 MM IN LENGTH IN A 4.91 MM VESSEL DIAMETER. THE LESION WAS MODERATELY CALCIFIED. A 7 MM MEDIUM SUPPORT AND A 5 MM MEDIUM SUPPORT ANGIOGUARD WERE DELIVERED PAST THE LESION AND AN 8X30 MM PRECISE PRO RX STENT WAS DEPLOYED AT THE TARGET LESION. THE ANGIOGUARD DEVICES WERE REMOVED WITHOUT ANY DIFFICULTY BUT IT IS UNKNOWN IF DEBRIS WAS FOUND IN THE BASKET. THE RESIDUAL DIAMETER STENOSIS MEASURED 10%. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE. POST-PROCEDURE NIH STROKE SCALE SCORE WAS 0, BUT RANKIN TEST WAS NOT PERFORMED. THE PATIENT WAS DISCHARGED ONE DAY AFTER THE PROCEDURE ON ASPIRIN AND CLOPIDOGREL. THE ADJUDICATION MINUTES RECEIVED INDICATED THAT ONE DAY AFTER THE DISCHARGE, THE PATIENT WAS HOSPITALIZED WITH A RIGHT FACIAL DROOP AND SLURRED SPEECH. A CT SCAN OF THE HEAD SHOWED NO SIGNIFICANT CHANGES COMPARED TO A STUDY PERFORMED ONE DAY PRIOR TO THE INDEX PROCEDURE. AN MRI WAS NOT PERFORMED DUE TO THE PATIENT'S AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. NIH AND RANKIN STROKE SCALE SCORES WERE NOT PERFORMED. THE NEUROLOGICAL ASSESSMENT ON THE FOLLOWING DAY SHOWED MILD DYSARTHRIA AND MILD RIGHT FACIAL DROOPING. A CAROTID DUPLEX SCAN ON THE SAME DAY REVEALED A PATENT LEFT CAROTID STENT. HOWEVER, THERE WAS AN INCREASE IN VELOCITY IN THE MID STENT. THE LEFT ICA STENOSIS WAS APPROXIMATELY 40%. A CT OF THE HEAD WITHOUT CONTRAST COMPLETED ONE DAY LATER SHOWED SLIGHT INDISTINCTNESS OF THE LATERAL GANGLIONIC REGION WHEN COMPARED TO THE PREVIOUS STUDY BEFORE THE INDEX. AN EARLY INFARCT IN THE AREA COULD NOT BE EXCLUDED. THE DISCHARGE SUMMARY NOTED THAT ON THE DAY OF DISCHARGE THE PATIENT'S RIGHT FACIAL DROOP WAS RESOLVED AND HIS SLURRING OF SPEECH WAS IMPROVING. THE SITE REPORTED PARTIAL RECOVERY WITH MINOR RESIDUAL DEFICITS. THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15019648

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization