BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE SDS SELF EXPANDING

    MDR report key: 3962942 · Received July 29, 2014

    Report

    Report Number
    9616099-2014-00497
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 4, 2011
    Report Date
    July 8, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K012993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR (4) PATIENTS WHO CANNOT TOLERATE THE COMBINED TREATMENT OF ANTIPLATELET AGGREGATION; (5) EXCESSIVE TORTUOUS ACCESS THAT CAUSED OPERATION FAILURE; AND SEVERE HEART, LUNG OR KIDNEY FAILURE. ALL PATIENTS WERE ADMINISTERED ASPIRIN 100 MG PER DAY AND CLOPIDOGREL 75 MG ORALLY PER DAY FOR 3 DAYS PRIOR TO THE PROCEDURE. UNDER A LOCAL ANESTHESIA, AN 8-FRENCH GUIDE CATHETER WAS PLACED IN THE COMMON CAROTID ARTERY VIA A FEMORAL VASCULAR SHEATH. A 0.014-IN MICROGUIDEWIRE OR A CEREBRAL PROTECTION DEVICE WAS CAREFULLY PASSED THROUGH THE TARGET LESION UNDER ROADMAP GUIDANCE, AND THE MICROGUIDEWIRE MUST BE ENSURED IN THE TRUE LUMEN OF THE ARTERY. THEN STENTS WERE EMPLOYED IN THE LESION. MULTIPLE STENTS WERE PLACED OVER THE WIDE-NECKED PSEUDOANEURYSM UNTIL THE ANGIOGRAPHY SHOWED THAT THE FLOW IN THE CAVITY OF THE PSEUDOANEURYSM DISAPPEARED. AFTER THE PROCEDURE, THE VASCULAR ACCESS SHEATH WAS REMOVED THROUGH MANUAL FEMORAL COMPRESSION. THERE WERE 29 MALE AND 4 FEMALE PATIENTS, RANGING IN AGE FROM 35 TO 51 YEARS (MEAN AGE, 40.21 YEARS). AMONG THE 33 PATIENTS, 27 SUFFERED FROM ISCHAEMIC STROKE, AND 6 SUFFERED FROM TIA. FIVE PATIENTS HAD A HEADACHE OR NECK PAIN PRIOR TO THE ONSET OF CAD, AND 2 PATIENTS OF THEM HAVE A HISTORY OF NECK TRAUMA. OF THE 33 PATIENTS, 3 HAD HYPERTENSION, 2 HAD DIABETES AND NO PATIENT SUFFERED FROM HYPERLIPIDEMIA. A TOTAL OF 2 PATIENTS HAVE A HISTORY OF SMOKING. THE VASCULAR INFLAMMATION INDICATIONS WERE NOT FOUND POSITIVE IN ALL PATIENTS. ALL PATIENTS EXCEPT ONE HAD SERIOUS STENOSIS (>75%). THREE CASES HAD DISSENTING ANEURYSM; OF THEM 1 CASE HAD BILATERAL CAD, AND THE OTHER 2 CASES HAD DISSENTING ANEURYSM SECONDARY TO THE TRAUMA OF THE COMMON CAROTID ARTERY (CCA). THE LESIONS OF CAD INVOLVED THE INTRACRANIAL INTERNAL CAROTID ARTERY (ICA) IN 1 PATIENT, THE INTERNAL CAROTID ARTERY AND COMMON CAROTID ARTERY AT THE SAME TIME IN 2 PATIENTS, AND THE EXTRACRANIAL INTERNAL CAROTID IN THE OTHER PATIENTS. OF ALL THE 33 PATIENTS, 32 HAD STENTS PLACED SUCCESSFULLY; 1 FAILED STENT PLACEMENT BECAUSE GUIDE WIRE FAILED TO CROSS THE TRUE LUMEN OF VESSEL OWING TO THE OCCLUSION THROUGHOUT THE INTERNAL CAROTID ARTERY. IN THE 32 PATIENTS THAT HAD STENTS PLACED SUCCESSFULLY, A TOTAL OF 45 STENTS WERE USED, AND CEREBRAL PROTECTION DEVICES WERE USED IN 13 PATIENTS. A PATIENT WHO SUFFERED FROM RECURRENT TIA PRIOR TO THE OPERATION HAD TRANSIENT INCOMPLETE HORNER SIGN AFTER THE OPERATION, AND THE TIA WAS COMPLETELY ELIMINATED UNTIL DOUBLE ANTIPLATELET WAS ADMINISTRATED FOR MORE THAN 6 MONTHS; NO NEW ISCHAEMIC STROKE OCCURRED IN THE OTHER PATIENTS. THE 32 PATIENTS WERE FOLLOWED UP FOR THE MEAN TIME OF 2.3 YEARS. EXCEPT THE ABOVE-MENTIONED TIA PATIENT, NO PATIENTS HAD RECURRENT IPSILATERAL ISCHEMIC EVENTS. THE DSA OR CTA EXAMINATIONS WERE CONDUCTED IN 15 PATIENTS ON THE 6 MONTH AND IN 7 ON THE 12 MONTHS AFTER THE OPERATION; THE EXAMINATIONS SHOWED THAT ALL CAD DISAPPEARED, THAT NO RESTENOSIS OCCURRED, AND THAT THE DISSECTING ANEURYSM DISAPPEARED IN THE TWO PATIENTS. THERE WAS NO INTRAOPERATIVE AND POSTOPERATIVE OCCURRENCE OF SYMPTOMATIC STROKE IN OUR CASE SERIES. THIRTY TWO PATIENTS WHO HAD ACHIEVED TECHNICAL SUCCESS WERE FOLLOWED UP AT A MEAN TIME OF 2.3 YEARS. THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW OF THIS DEVICE. THE CITATION IS AS FOLLOWS: YIN Q., LI Y., MA M., XU G., LIU X., ZHU W. (2011, (B)(4)). FEASIBILITY AND SAFETY OF STENTING FOR SYMPTOMATIC CAROTID ARTERIAL DISSECTION. CEREBROVASCULAR DISEASE, 32, 11-15. THIS IS THE INITIAL AND FINAL REPORT FOR THIS DEVICE. CONCOMITANT MEDICATIONS: PRE PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENT AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 9616099-2014-00496 &. 9616099-2014-00497. AS NOTED IN THE PUBLICATION BY YIN ET AL FEASIBILITY AND SAFETY OF STENTING FOR SYMPTOMATIC CAROTID ARTERIAL DISSECTION, CEREBROVASC DIS 32 (2011) 11-15; A (B)(6) MALE PATIENT HAD MANIFESTED IPSILATERAL HORNER SIGN ON THE NEXT DAY AFTER PRECISE STENTING. THE INNER LUMEN DIAMETER OF HIS AFFECTED EXTRACRANIAL ICA WAS ABOUT 6 MM BEFORE STENTING. EXCESSIVE DILATATION OF LOCAL BLOOD VESSELS COULD BE OBSERVED IMMEDIATELY WHEN TWO STENTS (8 MM × 40 MM, PRECISE¿) WERE EMBEDDED INTO C1 SEGMENT OF THE AFFECTED ICA. HORNER SIGN APPEARED ON THE NEXT DAY AFTER STENTING, WHICH MIGHT BE ASSOCIATED WITH THE CONTINUING OPPRESSION ON THE CERVICAL POSTGANGLIONIC SYMPATHETIC FIBERS BY THE EXCESSIVE DILATED ICA. BASED ON THE STATUS OF THE TARGET VASCULAR DIAMETERS ALTERED PREOPERATIVELY AND POSTOPERATIVELY, IT WAS CONSIDERED THAT THE UNDERLYING PATHOGENESIS OF THIS CAROTID ARTERY DISSECTION (CAD) PATIENT MIGHT BE FIBROMUSCULAR DISEASE (FMD). NATIONAL INSTITUTES OF HEALTH STROKE SCALE SCORE (NIHSS) WAS 2 AT BASELINE. RISK FACTORS INCLUDED SMOKING. THE LESION LOCATION WAS THE RIGHT INTERNAL CAROTID ARTERY, C1 SEGMENT OF INTERNAL CAROTID ARTERY. NIHSS WAS 0 ON THE DAY OF DISCHARGE FROM THE HOSPITAL. THE OBJECTIVE OF THE STUDY WAS TO DETERMINE THE PROCEDURAL FEASIBILITY AND SAFETY OF CAROTID ANGIOPLASTY AND STENT PLACEMENT OF CAROTID ARTERY DISSECTION (CAD) PATIENTS WHO HAD FAILED ANTITHROMBOTIC THERAPY IN ACUTE DISSECTION. A TOTAL OF 33 PATIENTS WITH CAD THAT WERE ALL CONFIRMED BY DSA WERE SELECTED FOR THIS STUDY FROM NANJING STROKE REGISTRY PROGRAM (NSRP). THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. HORNER SYNDROME IS A COMBINATION OF SIGNS AND SYMPTOMS CAUSED BY THE DISRUPTION OF A NERVE PATHWAY FROM THE BRAIN TO THE FACE AND EYE ON ONE SIDE OF THE BODY. TYPICALLY, HORNER SYNDROME RESULTS IN A DECREASED PUPIL SIZE, A DROOPING EYELID AND DECREASED SWEATING ON THE AFFECTED SIDE OF YOUR FACE. HORNER SYNDROME IS THE RESULT OF ANOTHER MEDICAL PROBLEM, SUCH AS A STROKE, TUMOR OR SPINAL CORD INJURY. IN SOME CASES, NO UNDERLYING CAUSE CAN BE FOUND. THERE'S NO SPECIFIC TREATMENT FOR HORNER SYNDROME, BUT TREATMENT FOR THE UNDERLYING CAUSE MAY RESTORE NORMAL NERVE FUNCTION. THE CLINICAL MANIFESTATION OF SPONTANEOUS CAROTID ARTERY DISSECTION (CAD) MAINLY INCLUDES IPSILATERAL HEADACHE OR NECK PAIN, HORNER SYNDROME, CEREBRAL OR OPHTHALMIC ISCHAEMIC EVENTS. MOREOVER, THE PRESENTATION OF HEADACHE AND NECK PAIN ALONG WITH HORNER SIGN IS A TYPICAL SYMPTOM OF THE ICA DISSECTION. OPPRESSION ON THE POSTGANGLIONIC SYMPATHETIC FIBERS BY LOCAL DISSECTING ANEURYSM MAY LIKELY CONTRIBUTE TO IPSILATERAL HORNER SIGN. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT REPORTED IN THE LITERATURE ARTICLE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY YIN ET AL FEASIBILITY AND SAFETY OF STENTING FOR SYMPTOMATIC CAROTID ARTERIAL DISSECTION, CEREBROVASC DIS 32 (2011) 11-15; A (B)(6) MALE PATIENT HAD MANIFESTED IPSILATERAL HORNER SIGN ON THE NEXT DAY AFTER PRECISE STENTING. THE INNER LUMEN DIAMETER OF HIS AFFECTED EXTRACRANIAL ICA WAS ABOUT 6 MM BEFORE STENTING. EXCESSIVE DILATATION OF LOCAL BLOOD VESSELS COULD BE OBSERVED IMMEDIATELY WHEN TWO STENTS (8 MM × 40 MM, PRECISE¿) WERE EMBEDDED INTO C1 SEGMENT OF THE AFFECTED ICA. HORNER SIGN APPEARED ON THE NEXT DAY AFTER STENTING, WHICH MIGHT BE ASSOCIATED WITH THE CONTINUING OPPRESSION ON THE CERVICAL POSTGANGLIONIC SYMPATHETIC FIBERS BY THE EXCESSIVE DILATED ICA. BASED ON THE STATUS OF THE TARGET VASCULAR DIAMETERS ALTERED PREOPERATIVELY AND POSTOPERATIVELY, IT WAS CONSIDERED THAT THE UNDERLYING PATHOGENESIS OF THIS CAD PATIENT MIGHT BE FIBROMUSCULAR DISEASE (FMD). NATIONAL INSTITUTES OF HEALTH STROKE SCALE SCORE (NIHSS) WAS 2 AT BASELINE. RISK FACTORS INCLUDED SMOKING. THE LESION LOCATION WAS THE RIGHT INTERNAL CAROTID ARTERY, C1 SEGMENT OF INTERNAL CAROTID ARTERY. NIHSS WAS 0 ON THE DAY OF DISCHARGE FROM THE HOSPITAL. THE OBJECTIVE OF THE STUDY WAS TO DETERMINE THE PROCEDURAL FEASIBILITY AND SAFETY OF CAROTID ANGIOPLASTY AND STENT PLACEMENT OF CAROTID ARTERY DISSECTION (CAD) PATIENTS WHO HAD FAILED ANTITHROMBOTIC THERAPY IN ACUTE DISSECTION. A TOTAL OF 33 PATIENTS WITH CAD THAT WERE ALL CONFIRMED BY DSA WERE SELECTED FOR THIS STUDY FROM NANJING STROKE REGISTRY PROGRAM (NSRP). THE INCLUSION CRITERIA WERE AS FOLLOWS: SYMPTOMATIC CAROTID ARTERY DISSECTION (SCAD) WITH SUBSEQUENT CAROTID ARTERY STENOSIS; AND PATIENTS WHO FAILED THE OPTIMAL MEDICAL THERAPY INCLUDING ANTICOAGULATION. THE EXCLUSION CRITERIA WERE AS FOLLOWS: ALLERGY TO CONTRAST AGENTS; SEVERE BLEEDING TENDENCY OR SEVERE THROMBOCYTOPENIA; PATIENTS WHO HAD ACTIVE BLEEDING OR SURGICAL OPERATIONS DURING THE PAST 3 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441948 PRECISE SDS SELF EXPANDING SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| S