BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET 360 NANO 2 MM X 3 CM

    MDR report key: 6873822 · Received September 18, 2017

    Report

    Report Number
    3008881809-2017-00341
    Event Type
    Injury
    Date Received
    September 18, 2017
    Date of Event
    August 6, 2015
    Report Date
    December 5, 2017
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K113412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE 4TH OF 13 REPORTS FILED ASSOCIATED WITH THIS EVENT. SUBJECT DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: ADDED. MANUFACTURING DATE: ADDED. 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 HEADACHE INCLUDING MIGRAINE SYNDROME AND NEUROLOGICAL/INTRACRANIAL SEQUELAE (NAUSEA, VOMITING, UNEQUAL PUPILS) ARE KNOWN RISKS 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.

    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 (SUBJECT DEVICE) AND ACCESS DEVICES. 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 (SUBJECT DEVICE) AND ACCESS DEVICES. 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
    653935 TARGET 360 NANO 2 MM X 3 CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 18193783

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R