BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2860965 · Received December 6, 2012

    Report

    Report Number
    9616099-2012-00735
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE SAPPHIRE REGISTRY, THE PATIENT HAD A SEIZURE APPROXIMATELY 5 DAYS POST INDEX PROCEDURE. THIS IS A (B)(6) FEMALE WITH MEDICAL HISTORY INCLUDING HYPERLIPIDEMIA, HISTORY OF SMOKING (>5 PACKS OF CIGARETTES), DIABETES MELLITUS, CORONARY ARTERY DISEASE, CORONARY PERCUTANEOUS REVASCULARIZATION AND HYPERTENSION (SYSTOLIC >140, OR DIASTOLIC >90, OR REQUIRING MEDICATION) AND HIGH RISK CRITERIA INCLUDES UNSTABLE ANGINA (CCS CLASS III/IV). BASELINE NIH SCORE WAS 2. THE PATIENT WAS SYMPTOMATIC AT THE TIME OF THE INTERVENTION. PTA WAS PERFORMED ON A 99% OCCLUDED LESION 20 MM IN LENGTH LOCATED IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. THE ARCH II LESION WAS ECCENTRIC, ULCERATED, MODERATELY TORTUOUS, AND MILDLY CALCIFIED WITH A REFERENCE DIAMETER OF 5.0 MM. AN EMBOLIC PROTECTION DEVICE MANUFACTURED BY ABBOTT WAS DEPLOYED AND A STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET SITE. THE STUDY SITE REPORTED THAT A CORDIS 10 X 40 MM PRECISE PRO RX NITINOL STENT SYSTEM WAS USED ON THIS SUBJECT. THE RESIDUAL DIAMETER STENOSIS MEASURED 5%. THE EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY REMOVED. THERE WAS NO DOCUMENTED DISSECTION OR PRESENCE OF AIR BUBBLES DURING THE PROCEDURE. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE SUITE. THE NIH STROKE SCORE WAS 1 AND THE RAKIN WAS 2 AT DISCHARGE. FIVE DAYS FOLLOWING THE INDEX PROCEDURE, AN ADVERSE EVENT OF NEUROLOGICAL DEFICIT (SEIZURE) WAS REPORTED. THE SITE REPORTED THE EVENT WAS DUE TO THE PATIENT HAD NOT TAKEN HER BP MEDICATION. THE STENT WAS PATENT. THE BP WAS ELEVATED TO 234/125 AND THE VOLUME OF BLOOD/PRESSURE TO THE BRAIN WAS WIDE OPEN. THE STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. 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 15690772 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NEUROLOGIC EVENTS, SPECIFICALLY SEIZURES, ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CAROTID ARTERY STENT PROCEDURE. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. CHANGES IN THE CEREBRAL BLOOD FLOW MAY CAUSE CHANGES IN THE BRAIN'S ELECTRICAL SYSTEM, POTENTIALLY LEADING TO SEIZURE ACTIVITY. REVIEW OF THE AVAILABLE INFORMATION DOES NOT SUGGEST WHAT CONTRIBUTING FACTORS MAY HAVE BEEN PRESENT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE DEVICE INDICATED IS A PRECISE STENT. THE CATALOG AND LOT NUMBERS ARE NOT CURRENTLY AVAILABLE BUT HAVE BEEN REQUESTED. THIS DEVICE IS ALSO NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. CONCOMITANT MEDICATIONS: BIVALRUDIN WAS GIVEN DURING THE PROCEDURE. PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE CATALOG # AND LOT # WERE RECEIVED. ADDITIONAL INFORMATION IS STILL PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) REGISTRY, POST-INDEX THE PATIENT HAD A SEIZURE. BASELINE NIH SCORE WAS 2. THE PATIENT WAS SYMPTOMATIC AT THE TIME OF THE INTERVENTION. PTA WAS PERFORMED ON A 99% OCCLUDED LESION 20 MM IN LENGTH LOCATED IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. THE ARCH II LESION WAS ECCENTRIC, ULCERATED, MODERATELY TORTUOUS, AND MILDLY CALCIFIED WITH A REFERENCE DIAMETER OF 5.0 MM. AN EMBOLIC PROTECTION DEVICE MANUFACTURED BY ABBOTT WAS DEPLOYED AND A STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET SITE. THE RESIDUAL DIAMETER STENOSIS MEASURED 5%. THE EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY REMOVED. THERE WAS NO DOCUMENTED DISSECTION OR PRESENCE OF AIR BUBBLES DURING THE PROCEDURE. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE SUITE. THE NIH STROKE SCORE WAS 1 AND THE RAKIN WAS 2 AT DISCHARGE. FIVE DAYS FOLLOWING THE INDEX PROCEDURE, AN ADVERSE EVENT OF NEUROLOGICAL DEFICIT (SEIZURE) WAS REPORTED. THE SITE REPORTED THE EVENT WAS DUE TO VESSEL PATENCY AND THE PATIENT HAD NOT TAKEN HER BP MEDICATION. THE BP WAS ELEVATED TO 234/125 AND THE VOLUME OF BLOOD/PRESSURE TO THE BRAIN WAS WIDE OPEN.

    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 15690772

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR ABBOTT EMBOLIC PROTECTION DEVICE: