BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    MDR report key: 14077923 · Received April 11, 2022

    Report

    Report Number
    1723170-2022-00538
    Event Type
    Injury
    Date Received
    April 11, 2022
    Date of Event
    August 11, 2021
    Report Date
    May 12, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY. THIS VALUE REFLECTS THE MEAN AGE OF THE PATIENTS WHO UNDERWENT THE EXTENDED ENDOSCOPIC TRANSSPHENOIDAL REMOVAL AND FPWC AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE MAJORITY GENDER OF THE PATIENTS WHO UNDERWENT THE EXTENDED ENDOSCOPIC TRANSSPHENOIDAL REMOVAL AND FPWC AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE ACCEPTED DATE. THE ARTICLE CITATION IS INCLUDED. THE SYSTEM WAS A STEALTH STATION. THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO 510K PROVIDED AS SYSTEM IS UNKNOWN. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    D1,D4,G2,G4, H4: THE MANUFACTURER REPRESENTATIVE PROVIDED THE PRODUCT ID AND SERIAL NUMBER. IT WAS ALSO NOTED THAT NO ADVERSE EVENTS WERE RELATED DIRECTLY TO MEDTRONIC DEVICES/PRODUCTS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    TOSAKA, M., PREVEDELLO, D. M., YAMAGUCHI, R., FUKUHARA, N., MIYAGISHIMA, T., TANAKA, Y., AIHARA, M., SHIMIZU, T., & YOSHIMOTO, Y. (2021). SINGLE-LAYER FASCIA PATCHWORK CLOSURE FOR THE EXTENDED ENDOSCOPIC TRANSSPHENOIDAL TRANSTUBERCULUM TRANSPLANUM APPROACH: DEEP SUTURING TECHNIQUE AND PRELIMINARY RESULTS. WORLD NEUROSURGERY, 155. HTTPS://DOI.ORG/10.1016/J.WNEU.2021.08.051 SUMMARY OBJECTIVE: TO DESCRIBE A SINGLE-LAYER FASCIA PATCHWORK CLOSURE (FPWC) WITHOUT NASOSEPTAL FLAP (NSF) AND COMPARE POSTOPERATIVE CEREBROSPINAL FLUID (CSF) LEAKAGE BETWEEN FPWC USING NSF AND SINGLE-LAYER FPWC WITHOUT NSF FOR THE EXTENDED ENDOSCOPIC TRANSSPHENOIDAL TRANSTUBERCULUM TRANSPLANUM APPROACH. METHODS: FORTY-FIVE CASES OF SUPRASELLAR TUMOR IN 42 PATIENTS WERE TREATED WITH EXTENDED ENDOSCOPIC TRANSSPHENOIDAL REMOVAL, RESULTING IN EXTENSIVE, HIGH-FLOW CSF LEAKAGE. FOLLOWING THE INTRADURAL PROCEDURE FOR TREATMENT OF VARIOUS SUPRASELLAR TUMORS, FASCIA LATA WAS INLAID SUBDURALLY ON THE CRANIAL BASE DEFECT AND PATCH-SUTURED AROUND ITS ENTIRE CIRCUMFERENCE UNDER ENDOSCOPE VISUALIZATION, USING AN AVERAGE OF 17 STITCHES. SEPTAL BONE OR HYDROXYAPATITE PLATE WAS USED FOR THE HARD SUPPORT MATERIAL AGAINST PULSATILE INTRACRANIAL PRESSURE. NSF WAS ADDED IN THE EARLIER 17 CASES. CLOSURE WAS COMPLETED WITHOUT NSF IN THE MORE RECENT 28 CASES WHEN THE VALSALVA MANEUVER CONFIRMED WATERTIGHT CLOSURE. TWO RECENT CASES REQUIRED NSF AFTER VALSALVA MANEUVER AND WERE INCLUDED IN THE FPWC D NSF GROUP. RESULTS: POSTOPERATIVE CSF LEAKAGE DID NOT OCCUR IN THE FPWC D NSF GROUP BUT OCCURRED IN 2 PATIENTS IN THE SINGLE-LAYER FPWC GROUP (7.1%) (P [ 0.52). THERE WAS NO SIGNIFICANT DIFFERENCE IN CSF LEAKAGE BETWEEN SINGLE-LAYER FPWC AND FPWC D NSF. THE MEAN SUTURING TIME FOR FPWC WAS 85.8 MINUTES, AND THE SHORTEST WAS 39 MINUTES IN A RECENT CASE. REPORTED EVENTS FORTY-TWO PATIENTS WITH A HISTOLOGY OF VARIOUS SUPRASELLAR TUMORS UNDERWENT EXTENDED ENDOSCOPIC TRANSSPHENOIDAL REMOVAL AND FPWC. FOUR PATIENTS HAD CSF LEAKAGE. TWO OF THESE LEAKAGES WERE IDENTIFIED POST-OPERATIVELY, AND REPAIR SURGERIES WERE PERFORMED JUST AFTER THE DIAGNOSIS. THE REOPERATIONS REQUIRED RESUTURING WITH ONLY ONE OR TWO KNOTS AT THE LEAKAGE POINT. THE OTHER TWO LEAKAGES WERE IDENTIFIED INTRA-OPERATIVELY AND WERE RESOLVED BY PERFORMING A RESCUE NSF. SIX PATIENTS HAD DETERIORATED VISUAL IMPAIRMENT SCORES. ONE PATIENT WITH XANTHOGRANULOMA EXPERIENCED POSTOPERATIVE SHORT-TERM MEMORY IMPAIRMENT. PERIOPERATIVELY, ONE PATIENT WAS FOUND TO HAVE PNEUMONIA. THIS ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210218 CART 9734056 S7 STAFF SHRT 100-120V INTL NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9734056

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other