BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 3031459 · Received April 2, 2013

    Report

    Report Number
    9616099-2013-00203
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 8, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE (B)(4) REGISTRY, THE PATIENT EXPERIENCED A SEIZURE DURING THE INDEX PROCEDURE. THE PATIENT HAD A FULL RECOVERY AND NO DEFICITS WERE OBSERVED. CATHLAB RECORDS INDICATE THAT 1 MG OF ATROPINE IV WAS GIVEN TO TREAT THE EVENT. BASELINE NIH WAS A 0. THE PATIENT WAS SYMPTOMATIC AT THE TIME OF INTERVENTION. PATIENT HAS A PRIOR MEDICAL HISTORY OF STROKE. PTCA WAS PERFORMED ON AN 80% OCCLUDED LESION 20 MM IN LENGTH IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY. THE ARCH I LESION WAS ECCENTRIC, MILDLY TORTUOUS AND MILDLY CALCIFIED. A 7 MM MEDIUM SUPPORT ANGIOGUARD RX DEVICE WAS DEPLOYED AND A 10 X 40 MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET SITE. A 5.0 X 30 MM AVIATOR PLUS BALLOON CATHETER WAS USED TO POST DILATE STENT PRIOR TO SEIZURE. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. THE ANGIOGUARD WAS SUCCESSFULLY REMOVED AND DEBRIS WAS FOUND IN THE BASKET. THERE WAS NO DOCUMENTED DISSECTION OR PRESENCE OF AIR BUBBLES DURING THE PROCEDURE. THE PATIENT HAD A SUDDEN NEUROLOGICALLY DEFICITS OF APHASIA WHICH OCCURRED DURING THE INDEX PROCEDURE. THE SITE REPORTED THAT THE DURATION OF THE SEIZURE WAS 6 MINUTES. THE SEIZURE OCCURRED WHILE THE ANGIOGUARD WAS IMPLANTED/ IN USE. THE DEFICITS APPEARED DURING POST-DILATATION. THE DURATION OF THE REPORTED EVENT WAS LESS THAN 24 HOURS. IN THE OPINION OF THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO THE CORDIS PRODUCT; HOWEVER IT WAS RELATED TO THE PROCEDURE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. AS WITH ANY INTERVENTIONAL PROCEDURE WHERE FOREIGN OBJECTS ARE INTRODUCED INTO THE PATIENTS VASCULATURE COMPLICATIONS CAN OCCUR. ONE POSSIBLE COMPLICATION OF BOTH CAROTID ENDARTERECTOMY AND CAROTID ANGIOPLASTY WITH STENTING INCLUDE, ALTHOUGH RARE, IS SEIZURES (BURSTS OF ABNORMAL ELECTRICAL SIGNALS THAT TEMPORARILY INTERRUPT NORMAL ELECTRICAL BRAIN FUNCTION). ONE POSSIBLE ETIOLOGY THAT IS CURRENTLY BEING INVESTIGATED IN THE LITERATURE IS HYPERPERFUSION, ALSO A WELL KNOWN POTENTIAL COMPLICATION OF THE CAROTID ARTERY STENTING PROCEDURE. EVIDENCE FROM OBSERVATIONAL STUDIES SUGGESTS THAT A NUMBER OF FACTORS - ALL REFERABLE TO HEMODYNAMIC EXHAUSTION OF THE CEREBRAL CIRCULATION-PLAY A ROLE IN HYPERPERFUSION SYNDROME, 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. 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. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 1016427-2013-00038 AND 9616099-2013-00204.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS: HEPARIN WAS GIVEN DURING THE PROCEDURE. PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. CONCOMITANT DEVICES: ANGIOGUARD RX: CATALOG NUMBER 701814RMC, LOT NUMBER 70912443; AVIATOR PLUS .014 5.0X30 142CM: CATALOG NUMBER 4245030W, LOT NUMBER 15467885 THIS DEVICE IS NOT AVAILABLE FOR TESTING OR EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 1016427-2013-00038 AND 9616099-2013-00204.

    Description of Event or Problem · 1

    AS REPORTED BY (B)(6), THE PATIENT EXPERIENCED A SEIZURE DURING THE INDEX PROCEDURE. BASELINE NIH WAS A 0. THE PATIENT WAS SYMPTOMATIC AT THE TIME OF INTERVENTION. PATIENT HAS A PRIOR MEDICAL HISTORY OF STROKE. PTCA WAS PERFORMED ON AN 80% OCCLUDED LESION 20 MM IN LENGTH IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY. THE ARCH I LESION WAS ECCENTRIC, MILDLY TORTUOUS AND MILDLY CALCIFIED. A 7 MM MEDIUM SUPPORT ANGIOGUARD RX DEVICE WAS DEPLOYED AND A 10 X 40 MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET SITE. A 5.0 X 30 MM AVIATOR PLUS BALLOON CATHETER WAS USED TO POST DILATE STENT PRIOR TO SEIZURE. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. THE ANGIOGUARD WAS SUCCESSFULLY REMOVED AND DEBRIS WAS FOUND IN THE BASKET. THERE WAS NO DOCUMENTED DISSECTION OR PRESENCE OF AIR BUBBLES DURING THE PROCEDURE. THE PATIENT HAD A SUDDEN NEUROLOGICALLY DEFICITS OF APHASIA WHICH OCCURRED DURING THE INDEX PROCEDURE. THE SITE REPORTED THAT THE DURATION OF THE SEIZURE WAS 6 MINUTES. THE SEIZURE OCCURRED WHILE THE ANGIOGUARD WAS IMPLANTED/ IN USE. CATHLAB RECORDS INDICATE THAT 1 MG OF ATROPINE IV WAS GIVEN TO TREAT THE EVENT. THE DEFICITS APPEARED DURING POST-DILATATION. THE DURATION OF THE REPORTED EVENT WAS LESS THAN 24 HOURS. IN THE OPINION OF THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO THE CORDIS PRODUCT; HOWEVER IT WAS RELATED TO THE PROCEDURE. THE PATIENT HAD A FULL RECOVERY AND NO DEFICITS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135172 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15556958

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention