BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1981192 · Received February 8, 2011

    Report

    Report Number
    9616099-2011-00084
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    September 11, 2010
    Report Date
    January 13, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE RETURNED WITHIN 30 DAYS FROM RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00083 AND 9616099-2011-00084.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00083 AND 9616099-2011-00084. AS REPORTED BY THE (B)(4) STUDY, THE PATIENT EXPERIENCED A LEFT HEMISPHERIC MCA ISCHEMIC STROKE FOUR MONTHS AFTER THE INDEX PROCEDURE. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY (ICA). THE LESION WAS DESCRIBED AS 90% STENOSED, NON-THROMBOSED, 30MM IN LENGTH, ARCH TYPE II WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 5.0MM IN DIAMETER AND MODERATELY TORTUOUS. THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE PROCEDURE. A 6MM ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION. THE LESION WAS PRE-DILATED WITH AN UNKNOWN BALLOON CATHETER AND AN 8X30MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED. A SECOND 9X30MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED OVERLAPPING THE FIRST STENT. THE ANGIOGUARD RX WAS SUCCESSFULLY RETRIEVED. IT WAS UNKNOWN IF THERE WAS DEBRIS IN THE BASKET. RESIDUAL STENOSIS WAS NOT PROVIDED. NO DISSECTION OCCURRED DURING THE PROCEDURE. THERE WERE NO AIR BUBBLES PRESENT. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. APPROXIMATELY FOUR MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED APHASIA AND RIGHT-SIDED HEMIPARESIS AND WAS DIAGNOSED WITH A STROKE. THE RECOVERY WAS PARTIAL WITH MINOR RESIDUALS. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT OR THE INDEX PROCEDURE. THE PATIENT'S MEDICAL HISTORY INCLUDES PRIOR RIGHT CAROTID ENDARTERECTOMY, HYPERLIPIDEMIA, SMOKING, AND HYPERTENSION. (B)(4): 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 15012493 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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. (B)(4): 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 14029175 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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. ISCHEMIC STROKE IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND CAN BE DEFINED AS A CEREBROVASCULAR DISORDER CAUSED BY DEPRIVATION OF BLOOD FLOW TO AN AREA OF THE BRAIN, GENERALLY AS A RESULT OF THROMBOSIS, EMBOLISM, OR REDUCED BLOOD PRESSURE. 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.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00083 AND 9616099-2011-00084. (B)(4): 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 LOTS 15012493 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. (B)(4). THE LOT WAS ACCEPTED AND RELEASED. THIS PROCESS TO HOLD BARES NO RELATION TO THE COMPLAINT REPORTED. (B)(4): 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 4029175 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO EXCURSIONS WERE FOUND FOR 14029175. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT.

    Description of Event or Problem · 1

    THE PATIENT DID NOT HAVE ANY ALLERGIES TO NITINOL, NICKEL, OR TITANIUM. A 6FR SHEATH INTRODUCER WAS USED. A TIGHT SEAL WAS MAINTAINED BETWEEN THE STENT DELIVERY SYSTEM AND THE TUOHY BORST (HEMOSTASIS) VALVE OF THE SHEATH INTRODUCER/GUIDING CATHETER DURING ASPIRATION. THERE WAS NO ASPIRATION PRIOR TO CONTRAST AS A CLOSED SYSTEM WAS USED. THERE WAS NO THROMBUS POST-DEPLOYMENT. THE STROKE OCCURRED ON THE LEFT HEMISPHERE (MCA) STROKE. LEFT-SIDED BRAIN SYMPTOMS INCLUDED EXPRESSIVE APHASIA, SLURRING OF SPEECH, RIGHT UPPER AND LOWER EXTREMITY WEAKNESS. TREATMENT INCLUDED PLAVIX, COUMADIN, AND REHAB (PHYSICAL THERAPY, OCCUPATIONAL THERAPY, AND SPEECH THERAPY). RESIDUAL SYMPTOMS INCLUDED NUMBNESS IN ONLY THE 4TH AND 5TH FINGERS, HER EYES NOT WORKING TOGETHER, AND OCCASIONAL DISTURBANCE OF HER RIGHT EYE'S VISION. THE CURRENT STATUS OF THE PATIENT WAS THAT SHE CONTINUES OUTPATIENT THERAPY, LIVES INDEPENDENTLY, AND IS SCHEDULED IN HER PHYSICIAN'S OFFICE FOR ROUTINE 6 MONTH FOLLOW-UP IN THE EARLY SUMMER. THE ADVERSE EVENT OCCURRED AFTER A GYNECOLOGICAL PROCEDURE IN (B)(6) 2010 AND THE SITE WAS NOT INFORMED OF THE EVENT UNTIL THE PATIENT CAME IN FOR HER ROUTINE FOLLOW-UP.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, THE PATIENT EXPERIENCED AN ISCHEMIC STROKE FOUR MONTHS AFTER THE INDEX PROCEDURE. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY (ICA). THE LESION WAS DESCRIBED AS 90% STENOSED, NON-THROMBOSED, 30MM IN LENGTH, ARCH TYPE II WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 5.0MM IN DIAMETER AND MODERATELY TORTUOUS. THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE PROCEDURE. A 6MM ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION. THE LESION WAS PRE-DILATED WITH AN UNKNOWN BALLOON CATHETER AND AN 8X30MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED. A SECOND 9X30MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED OVERLAPPING THE FIRST STENT. THE ANGIOGUARD RX WAS SUCCESSFULLY RETRIEVED. IT WAS UNKNOWN IF THERE WAS DEBRIS IN THE BASKET. RESIDUAL STENOSIS WAS NOT PROVIDED. NO DISSECTION OCCURRED DURING THE PROCEDURE. THERE WERE NO AIR BUBBLES PRESENT. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. APPROXIMATELY FOUR MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED APHASIA AND RIGHT-SIDED HEMIPARESIS AND WAS DIAGNOSED WITH A STROKE. THE RECOVERY WAS PARTIAL WITH MINOR RESIDUALS. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT OR THE INDEX PROCEDURE.

    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 14029175

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other 6MM ANGIOGUARD RX.