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Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Inflammation (1932); Renal Failure (2041); Urinary Tract Infection (2120); Convulsion/Seizure (4406)
Event Date 05/01/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: u nk_nav_comp, serial/lot #: unk unk_nav_comp represents the axiem stylet. Patient information was not included in the journal entry this value reflects the average age of the patients who underwent the mis procedure as specific patients could not be identified. This value reflects the majority gender of the patients who underwent the mis procedure as specific patients could not be identified. The event date was not provided in the article. The date provided is the published date. The article citation is included. The system product number and serial number were not provided in the journal article. Udi not available for this system. The instrument product number and lot number were not provided in the journal article. Udi not available for this instrument. 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.
Event Description
World neurosurg. (2021) 149:e592-e599. Https://doi. Org/10. 1016/j. Wneu. 2021. 01. 128 summary background: intracerebral hemorrhage (ich) is the most devastating form of stroke, with thalamic hemorrhages carrying the worst outcomes. Minimally invasive (mis) endoscopic ich evacuation is a promising new therapy for the condition. However, it remains unclear whether therapy success is location dependent. Here we present long-term functional outcomes after mis evacuation of spontaneous thalamic hemorrhages. Methods: patients presenting to a single urban health system with spontaneous ich were triaged to a central hospital for management of ich. Operative criteria for mis evacuation included hemorrhage volume ¿15 ml, age ¿18, national institutes of health stroke scale ¿6, and baseline modified rankin score (mrs) £3. Demographic, radiographic, and clinical data were collected prospectively, and descriptive statistics were performed retrospectively. Functional outcomes were assessed using 6-month mrs scores. Results: endoscopic ich evacuation was performed on 21 patients. Eleven patients had hemorrhage confined to the thalamus, whereas 10 patients had hemorrhages in the thalamus and surrounding structures. Eighteen patients (85. 7%) had intraventricular extension. The average preoperative volume was 39. 8 ml (standard deviation [sd]: 31. 5 ml) and postoperative volume was 3. 8 ml (sd: 6. 1 ml), resulting in an average evacuation rate of 91. 4% (sd: 11. 1%). One month after hemorrhage, 2 patients (9. 5%) had expired and all other patients remained functionally dependent (90. 5%). At 6-month follow-up, 4 patients (19. 0%) had improved to a favorable outcome (mrs £ 3). Conclusion: among patients with ich undergoing medical management, those with thalamic hemorrhages have especially poor outcomes. This study suggests that mis evacuation can be safely performed in a thalamic population. It also presents long-term functional outcomes that can aid in planning randomization schemes or subgroup analyses in future mis evacuation clinical trials. Reported events: twelve patients with a histology of ich underwent a mis endoscopic ich evacuation. There were medical complications that included ten cases of pneumonia, two cases of ventriculitis, two cases of gastrointestestinal bleeding, two cases of acute kidney injury, one case of seizure, and readmission for urinary tract infections sepsis. See attached article.
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Manufacturer (Section D)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key12579460
MDR Text Key274920287
Report Number1723170-2021-02437
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK_NAV_SYS
Device Catalogue NumberUNK_NAV_SYS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/05/2021 Patient Sequence Number: 1