BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 6213745 · Received December 29, 2016

    Report

    Report Number
    3008881809-2016-00335
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    July 7, 2016
    Report Date
    March 9, 2017
    Manufacturer
    STRYKER NEUROVASCULAR-CALIF
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EXACT DATE OF THE ADVERSE EVENT IS UNKNOWN. ALL PATIENTS WERE TREATED BETWEEN JANUARY 2013 TO JUNE 2015.COMPLAINT #12: THIS IS 12 OF 19 REPORTS FOR THIS ARTICLE. THE SUBJECT DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT #12: THIS IS 12 OF 19 REPORTS FOR THIS ARTICLE (INCLUDING MFR# 3008881809-2016-00331 HAS BEEN REDACTED AFTER FURTHER REVIEW OF THE LITERATURE ARTICLE). PLEASE SEE MFR REPORT# BELOW FOR THE OTHER REPORTS SUBMITTED ON THE SAME ARTICLE. 0002134265-2016-00041; 3008881809-2016-00333; 0002134265-2016-00040; 3008881809-2016-00330; 0002134265-2016-00038; 3008881809-2016-00331 (REDACTED); 0002134265-2016-00039; 3008881809-2016-00332; 0002134265-2016-00042; 3008881809-2016-00334; 0002134265-2016-00043; 0002134265-2016-00044; 3008881809-2016-00336; 0002134265-2016-00037; 0002134265-2016-00045; 3008881809-2016-00338; 3008881809-2016-00337; 0002134265-2016-00046. ADDITIONAL MANUFACTURER NARRATIVE: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, PATIENT STROKE IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND PATIENT CONDITION, AND IS LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE. THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    THE ARTICLE PRESENTED RETROSPECTIVE EVALUATION OF EXPERIENCE FOR ONE-SINGLE SITE OF THE FACTORS AFFECTING THE RISK OF PERFORATOR STROKE AFTER BASILAR ARTERY ANGIOPLASTY AND/OR STENTING. A TOTAL OF 255 PATIENTS WERE INCLUDED IN THE STUDY, AND THE DECISION TO PERFORM ENDOVASCULAR TREATMENT AS WELL AS THE STENT TYPE WERE MADE BASED ON ARTERIAL ACCESS AND LESION MORPHOLOGY. FOR THOSE WITH TORTUOUS ACCESS AND MORI B OR C LESIONS OR IF THE DIAMETERS OF THE PROXIMAL AND DISTAL SEGMENTS WERE SIGNIFICANTLY DIFFERENT, ANGIOPLASTY PLUS A SELF-EXPANDING STENT (BALLOON PLUS SUBJECT STENT SYSTEM) WAS PREFERRED. FOR PATIENTS WITH TORTUOUS ARTERIAL ACCESS WITH A MORI A LESION OR A SMALL TARGET VESSEL DIAMETER (<2.5 MM), ANGIOPLASTY ALONE WITH A BALLOON WAS SELECTED. PROCEDURE-RELATED PERFORATOR STROKE WAS IDENTIFIED IN 13 PATIENTS (5.1%). EXCEPT FOR PERFORATOR STROKE SOME PATIENTS HAD SOME OTHER COMPLICATIONS. PATIENT#12 (TABLE 2): THIS PATIENT WAS MORI TYPE C. IT WAS REPORTED THAT THERE WAS NO COMPLICATIONS DURING PROCEDURE. AND 3 DAYS AFTER PROCEDURE, THE PATIENT HAD PERFORATOR STROKE WITH SYMPTOMS OF LEFT UPPER EXTREMITY AND LEFT FACE NUMBNESS, TURNED TO LEFT EXTREMITIES WEAKNESS 2 DAYS LATER.

    Description of Event or Problem · 1

    THE ARTICLE PRESENTED RETROSPECTIVE EVALUATION OF EXPERIENCE FOR ONE-SINGLE SITE OF THE FACTORS AFFECTING THE RISK OF PERFORATOR STROKE AFTER BASILAR ARTERY ANGIOPLASTY AND/OR STENTING. A TOTAL OF 255 PATIENTS WERE INCLUDED IN THE STUDY, AND THE DECISION TO PERFORM ENDOVASCULAR TREATMENT AS WELL AS THE STENT TYPE WERE MADE BASED ON ARTERIAL ACCESS AND LESION MORPHOLOGY. FOR THOSE WITH TORTUOUS ACCESS AND MORI B OR C LESIONS OR IF THE DIAMETERS OF THE PROXIMAL AND DISTAL SEGMENTS WERE SIGNIFICANTLY DIFFERENT, ANGIOPLASTY PLUS A SELF-EXPANDING STENT (BALLOON PLUS STENT SYSTEM) WAS PREFERRED. FOR PATIENTS WITH TORTUOUS ARTERIAL ACCESS WITH A MORI A LESION OR A SMALL TARGET VESSEL DIAMETER (<2.5 MM), ANGIOPLASTY ALONE WITH A BALLOON WAS SELECTED. PROCEDURE-RELATED PERFORATOR STROKE WAS IDENTIFIED IN 13 PATIENTS (5.1%). EXCEPT FOR PERFORATOR STROKE SOME PATIENTS HAD SOME OTHER COMPLICATIONS. PATIENT#12 (TABLE2): THIS PATIENT WAS MORI TYPE C AND TREATED WITH ANGIOPLASTY PLUS A SELF-EXPANDING STENT (BALLOON PLUS SUBJECT STENT SYSTEM). IT WAS REPORTED THAT THERE WAS NO COMPLICATIONS DURING PROCEDURE. AND 3 DAYS AFTER PROCEDURE, THE PATIENT HAD PERFORATOR STROKE WITH SYMPTOMS OF LEFT UPPER EXTREMITY AND LEFT FACE NUMBNESS, TURNED TO LEFT EXTREMITIES WEAKNESS 2 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862843 UNKNOWN_NEUROVASCULAR_PRODUCT STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR-CALIF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GATEWAY BALLOON ((B)(4))