BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHRO 2/14 200 CM STANDARD

    MDR report key: 6874809 · Received September 18, 2017

    Report

    Report Number
    3008880413-2017-00042
    Event Type
    Injury
    Date Received
    September 18, 2017
    Date of Event
    August 6, 2015
    Report Date
    November 27, 2017
    Manufacturer
    STRYKER NEUROVASCULAR-UTAH
    Product Code
    DQX
    PMA / PMN Number
    K053268
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, PHYSICAL AS WELL AS A FUNCTIONAL TESTING COULD NOT BE PERFORMED. HOWEVER, NEUROLOGICAL/INTRACRANIAL SEQUELAE (HEADACHE) IS A KNOWN RISK ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND NOTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WAS ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THIS IS THE 13TH OF 13 REPORTS FILED ASSOCIATED WITH THIS EVENT: THE PATIENT SYMPTOMS OF NAUSEA, VOMITING AND VISUAL DISTURBANCES OCCURRED 45 DAYS POST THE INDEX PROCEDURE. THEREFORE, ONLY THE PATIENT CODE OF HEADACHE IS RELEVANT TO THIS SPECIFIC ACCESS DEVICE FILLING. ONLY THE IMPLANTED DEVICES (STENT AND COILS) WERE PRESENT AT THE TIME OF THE PATIENT SYMPTOMS (NAUSEA, VOMITING, VISUAL DISTURBANCE) AND NOT THE ACCESS DEVICES (SUBJECT GUIDEWIRE). SUBJECT DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN UN-RUPTURED ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY (ACOM). POST-PROCEDURE THE PATIENT WAS ASSESSED HAVING A MODIFIED RANKING SCALE (MRS) OF 0. IT WAS REPORTED THAT ON THE DAY OF THE PROCEDURE THE PATIENT EXPERIENCED HEADACHE AND MEDICATION WAS ADMINISTERED. THE HEADACHE LASTED APPROXIMATELY 1 MONTH POST-PROCEDURE AND WAS RESOLVED WITHOUT ANY RESIDUAL EFFECTS. APPROXIMATELY 45 DAYS POST PROCEDURE, THE PATIENT EXPERIENCED MIGRAINE SYNDROME INCLUDING NAUSEA, VOMITING, AND UNEQUAL PUPILS; HOWEVER, CT SCAN WAS NEGATIVE. MEDICATION (UNKNOWN TYPE AND DOSE) WAS ADMINISTERED AND OUT-PATIENT VISIT TO THE EMERGENCY DEPARTMENT WAS REQUIRED. ACCORDING TO THE PHYSICIAN, THE HEADACHE WAS POSSIBLY RELATED TO THE PROCEDURE AND STENT. IN ADDITION, THE PHYSICIAN INDICATED THAT THE MIGRAINE WAS UNRELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE STENT. HOWEVER, IT IS UNKNOWN IF THE HEADACHE AND MIGRAINE WERE RELATED TO IMPLANTED COILS AND ACCESS DEVICES (SUBJECT DEVICE). DURING THE 2 AND 6 MONTHS FOLLOW-UP, THE PATIENT WAS ASSESSED HAVING A MRS OF 0. AT THE 12 MONTHS FOLLOW-UP POST THE INDEX PROCEDURE, THE PATIENT WAS ASSESSED HAVING A NIHHS AND MRS OF 0. THE PATIENT DID NOT REPORT HEADACHES AFTER THE 6 MONTHS VISIT BUT THE MIGRAINE SYNDROME WAS STILL INTERMITTENTLY CONTINUING. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN UN-RUPTURED ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY (ACOM). POST-PROCEDURE THE PATIENT WAS ASSESSED HAVING A MODIFIED RANKING SCALE (MRS) OF 0. IT WAS REPORTED THAT ON THE DAY OF THE PROCEDURE THE PATIENT EXPERIENCED HEADACHE AND MEDICATION WAS ADMINISTERED. THE HEADACHE LASTED APPROXIMATELY 1 MONTH POST-PROCEDURE AND WAS RESOLVED WITHOUT ANY RESIDUAL EFFECTS. APPROXIMATELY 45 DAYS POST PROCEDURE, THE PATIENT EXPERIENCED MIGRAINE SYNDROME INCLUDING NAUSEA, VOMITING, AND UNEQUAL PUPILS; HOWEVER, CT SCAN WAS NEGATIVE. MEDICATION (UNKNOWN TYPE AND DOSE) WAS ADMINISTERED AND OUT-PATIENT VISIT TO THE EMERGENCY DEPARTMENT WAS REQUIRED. ACCORDING TO THE PHYSICIAN, THE HEADACHE WAS POSSIBLY RELATED TO THE PROCEDURE AND STENT. IN ADDITION, THE PHYSICIAN INDICATED THAT THE MIGRAINE WAS UNRELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE STENT. HOWEVER, IT IS UNKNOWN IF THE HEADACHE AND MIGRAINE WERE RELATED TO IMPLANTED COILS AND ACCESS DEVICES (SUBJECT DEVICE). DURING THE 2 AND 6 MONTHS FOLLOW-UP, THE PATIENT WAS ASSESSED HAVING A MRS OF 0. AT THE 12 MONTHS FOLLOW-UP POST THE INDEX PROCEDURE, THE PATIENT WAS ASSESSED HAVING A NIHHS AND MRS OF 0. THE PATIENT DID NOT REPORT HEADACHES AFTER THE 6 MONTHS VISIT BUT THE MIGRAINE SYNDROME WAS STILL INTERMITTENTLY CONTINUING. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653378 SYNCHRO 2/14 200 CM STANDARD WIRE, GUIDE, CATHETER DQX STRYKER NEUROVASCULAR-UTAH B37160

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R