BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 3153625 · Received June 8, 2013

    Report

    Report Number
    9616099-2013-00355
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 20, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CT SCAN OF THE HEAD WAS PERFORMED AND NOTED THAT CONTRAST WAS SEEN WITHIN THE ARTERIES AND VEINS CONSISTENT WITH RECENT CAROTID STENT PLACEMENT. THERE IS CHRONIC ENCEPHALOMALACIA INVOLVING THE RIGHT OCCIPITAL LOBE POSTERIO-MEDIALLY CONSISTENT WITH CHRONIC INFARCT, UNCHANGED. THERE IS A TINY FOCAL HYPO ATTENUATING REGION WITHIN THE LEFT FRONTAL CORTEX WHICH HAS A SUB-ACUTE TO CHRONIC APPEARANCE AND LIKELY REPRESENTS SUB-ACUTE OR CHRONIC CORTICAL INFARCT, WHICH APPEARS TO BE PRESENT ON THE PRIOR EXAMINATION. NO DEFINITE ACUTE VASCULAR TERRITORY INFARCT IS SEEN. THE VENTRICLES ARE NORMAL IN SIZE AND MORPHOLOGY. THERE IS NO MASS EFFECT OR MIDLINE SHIFT. THE BASILAR CISTERNS ARE PATENT. THE GRAY-WHITE MATTER DIFFERENTIATION IS OTHERWISE PRESERVED. THERE IS MILD MUCOSAL THICKENING WITHIN THE ETHMOID SINUSES. THE REMAINDER OF THE VISUALIZED PARANASAL SINUSES, ORBITS, AND MASTOIDS ARE NORMAL. NO ACUTE INTRACRANIAL ABNORMALITY TO SUGGEST ACUTE HEMORRHAGE, MASS, OR STROKE. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY (B)(4), INDICATED THAT POST CAROTID STENT THE PATIENT EXPERIENCED THE EVENT OF CEREBRAL HYPERPERFUSION SYNDROME. THE PATIENT IS A (B)(6) MALE WHO WAS ENROLLED IN (B)(4) FOR STENTING OF THE CAROTID ARTERY. POST- ENDARTERECTOMY RESTENOSIS IS AN INDICATION FOR CAROTID STENTING. THE TARGET LESION LOCATION WAS THE MID LEFT INTERNAL CAROTID ARTERY (L4). THE VESSEL WAS DESCRIBED AS ECCENTRIC AND MILDLY CALCIFIED. THE RATE OF STENOSIS WAS 90%. ACCESS WAS MADE WITH A 6FR. SHEATH IN THE RIGHT FEMORAL ARTERY. A DIAGNOSTIC ANGIOGRAM WAS PERFORMED. A 6X90MM SHUTTLE SHEATH WAS INSERTED. A 5.0 ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS DEPLOYED DISTAL TO THE LESION AND THE LESION WAS PRE-DILATED WITH A 3X20MM BALLOON. A PRECISE STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION AND POST DILATED WITH A 5.0 VIATRAC BALLOON AT 8 ATMOSPHERES. POST INTERVENTION ANGIOGRAPHY REVEALS 0% RESIDUAL STENOSIS. INTRACRANIAL ANGIOGRAPHY REVEALED SOME INTRACRANIAL DISEASE OF 50/60% IN THE PROXIMAL MIDDLE CEREBRAL ARTERY. IT WAS NOTED THAT THERE IS POOR FILLING OF THE ANTERIOR CEREBRAL ARTERY. THE PROCEDURE WAS COMPLETED. THE ANGIOGUARD WAS SAFELY REMOVED FROM THE PATIENT. AFTER THE ANGIOGUARD WAS REMOVED THE PATIENT SUFFERED NEUROLOGICAL DEFICITS DESCRIBED AS REFLEX CHANGE, VISUAL FIELD LOSS IN EYES, HEMIPARESIS ON THE RIGHT, HEMITAXIA ON THE RIGHT. THE PATIENT WAS TREATED MEDICALLY WITH A FLUID FLUSH, AND MEDICATION. THE ONSET WAS GRADUAL; RECOVERY WAS FULL IN LESS THAN 24 HOURS. DIAGNOSIS WAS CEREBRAL HYPERPERFUSION SYNDROME, UNRELATED TO THE CORDIS PRODUCTS BUT RELATED TO THE INDEX PROCEDURE. NEUROLOGIC EXAM THE NEXT DAY SHOWED EQUAL HAND GRIP BILATERALLY AND NO FURTHER NUMBNESS IN HIS RIGHT HAND. THERE WERE NO VISUAL CHANGES. LOWER EXTREMITY MOTOR AND SENSORY FUNCTION WERE UNAFFECTED. THE PATIENT WAS UP AND AMBULATING WITHOUT DIFFICULTY. THE PATIENT WAS DISCHARGED WITH ASPIRIN AND PLAVIX PRESCRIBED. A CT SCAN OF THE HEAD WAS PERFORMED AND NOTED THAT CONTRAST WAS SEEN WITHIN THE ARTERIES AND VEINS CONSISTENT WITH RECENT CAROTID STENT PLACEMENT. THERE WAS CHRONIC ENCEPHALOMALACIA INVOLVING THE RIGHT OCCIPITAL LOBE POSTERIO-MEDIALLY CONSISTENT WITH CHRONIC INFARCT, UNCHANGED. THERE IS A TINY FOCAL HYPO ATTENUATING REGION WITHIN THE LEFT FRONTAL CORTEX WHICH HAS A SUB-ACUTE TO CHRONIC APPEARANCE AND LIKELY REPRESENTS SUB-ACUTE OR CHRONIC CORTICAL INFARCT, WHICH APPEARS TO BE PRESENT ON THE PRIOR EXAMINATION. NO DEFINITE ACUTE VASCULAR TERRITORY INFARCT IS SEEN. THE CT SCAN SHOWED NO ACUTE INTRACRANIAL ABNORMALITY TO SUGGEST ACUTE HEMORRHAGE, MASS, OR STROKE. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. HYPERPERFUSION SYNDROME IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CAROTID STENT IMPLANTATION. NUMEROUS REPORTS HAVE DOCUMENTED THE RISK OF HYPERPERFUSION SYNDROME AFTER CAROTID ENDARTERECTOMY, CAROTID ANGIOPLASTY AND INTRACRANIAL ANGIOPLASTY. EVIDENCE FROM OBSERVATIONAL STUDIES 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 AN IPSILATERAL PEAK MIDDLE CEREBRAL ARTERY FLOW VELOCITY IN ADDITION TO PRE- AND POSTOPERATIVE HYPERTENSION. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL AND PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE HYPERPERFUSION SYNDROME. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL AND PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY INDICATED THAT POST CAROTID STENT THE PATIENT EXPERIENCED THE EVENT OF CEREBRAL HYPERPERFUSION SYNDROME. THE PATIENT IS A (B)(6) MALE WHO WAS ENROLLED IN THE (B)(4) STUDY FOR STENTING OF THE CAROTID ARTERY. POST- ENDARTERECTOMY RESTENOSIS IS AN INDICATION FOR CAROTID STENTING. THE TARGET LESION LOCATION WAS THE MID LEFT INTERNAL CAROTID ARTERY (L4). THE VESSEL WAS DESCRIBED AS ECCENTRIC AND MILDLY CALCIFIED. THE RATE OF STENOSIS WAS 90%. ACCESS WAS MADE WITH A 6FR. SHEATH IN THE RIGHT FEMORAL ARTERY. A DIAGNOSTIC ANGIOGRAM WAS PERFORMED. A 6X90MM SHUTTLE SHEATH WAS INSERTED. A 5.0 ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS DEPLOYED DISTAL TO THE LESION AND THE LESION WAS PRE-DILATED WITH A 3X20MM BALLOON. A PRECISE STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION AND POST DILATED WITH A 5.0 VIATRAC BALLOON AT 8 ATMOSPHERES. POST INTERVENTION ANGIOGRAPHY REVEALS 0% RESIDUAL STENOSIS. INTRACRANIAL ANGIOGRAPHY REVEALED SOME INTRACRANIAL DISEASE OF 50/60% IN THE PROXIMAL MIDDLE CEREBRAL ARTERY, THERE IS POOR FILLING OF THE ANTERIOR CEREBRAL ARTERY. THE PROCEDURE WAS COMPLETED. THE ANGIOGUARD WAS SAFELY REMOVED FROM THE PATIENT. AFTER THE ANGIOGUARD WAS REMOVED THE PATIENT SUFFERED NEUROLOGICAL DEFICITS DESCRIBED AS REFLEX CHANGE, VISUAL FIELD LOSS IN EYES, HEMIPARESIS ON THE RIGHT, HEMITAXIA ON THE RIGHT. THE PATIENT WAS TREATED MEDICALLY WITH A FLUID FLUSH, AND MEDICATION. THE ONSET WAS GRADUAL; RECOVERY WAS FULL IN LESS THAN 24 HOURS. DIAGNOSIS WAS CEREBRAL HYPERPERFUSION SYNDROME, UNRELATED TO THE CORDIS PRODUCTS BUT RELATED TO THE INDEX PROCEDURE. NEUROLOGIC EXAM THE NEXT DAY SHOWED EQUAL HAND GRIP BILATERALLY AND NO FURTHER NUMBNESS IN HIS RIGHT HAND. THERE WERE NO VISUAL CHANGES. LOWER EXTREMITY MOTOR AND SENSORY FUNCTION WERE UNAFFECTED. THE PATIENT WAS UP AND AMBULATING WITHOUT DIFFICULTY. THE PATIENT WAS DISCHARGED WITH ASPIRIN AND PLAVIX PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258846 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15772435

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R ANGIOGUARD, VIATRAC BALLOON