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Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Neurological Deficit/Dysfunction (1982); Meningitis (2389); Post Operative Wound Infection (2446)
Event Date 10/01/2019
Event Type  Injury  
Manufacturer Narrative
Patient age is average age of patients in the treatment cohort for the article. Patient gender is the majority gender of patients in the treatment cohort for the article. Date of event: please note that this date is based off of the date the article was published as the event dates were not provided in the published literature. Article citation is included. System product number and serial number not provided in journal article. Udi not available for this system. No 510k provided as system is unknown. No evaluation was performed as this event was reported in literature. Device manufacturing date is unavailable. If information is provided in the future, a supplemental report will be issued.
Event Description
Citation: bassaganyas-vancells, et al. ¿combined use of 5-aminolevulinic acid and intraoperative low-field magnetic resonance imaging in high-grade glioma surgery. ¿ world neurosurgery. Oct. 2019;130:e206-e212. Https://doi. Org/10. 1016/j. Wneu. 2019. 06. 029 abstract: objective: we sought to assess the impact of 5-aminolevulinic acid (5-ala) and low-field intraoperative magnetic resonance imaging (imri) on the extent of resection of high-grade gliomas (hggs). Results are compared with those obtained when using 5-ala and imri separately. Methods: we retrospectively included patients with an hgg eligible for gross total resection (gtr) from january 2013 to january 2018. Patients were included according to 5-ala surgical guidance (5a-group), imri (imri-group), or both (5a-imri-group). Surgical variables were registered, and presurgical and postsurgical radiologic and clinical variables were analyzed. Extent of resection greater or equal to 90%, complications, and new permanent neurologic deficit were compared using the chi-squared and analysis of variance tests. Other variables studied were mortality, average hospital stay, surgical time, and karnofsky performance scale status before and after surgery. Results: most of the 118 procedures carried out were in men (59. 2%). The mean age was 58 years. Sixty patients (50. 8%) were operated on using exclusively 5-ala assistance (5a-group), 19 (16. 1%) using imri (imri-group), and 39 (33%) combining both techniques (5a-imri-group). There were no statistically significant differences among 3 groups regarding extent of resection greater or equal to 90% (73% 5a, 73. 7% imri, 71. 8% 5a-imri, p
0. 94); complication rates (18. 3% 5a, 5. 3% imri, 7. 7% 5a-imri, p
0. 17); new or worsening of preexisting neurologic deficit at 1-month follow-up (13. 3% 5a, 10. 5% imri, 15. 4% 5a-imri, p
0. 26); average hospital stay in days (9. 5 5a, 6. 4 imri, 7. 6 5a-imri, p
0. 18); karnofsky performance scale; nor surgical time in minutes (212. 4 5a, 187. 9 imri, 201. 4 5a-imri, p
0. 13). Conclusions: in our experience, combined use of imri and 5-ala does not improve the studied variables when compared with those technologies when used separately, even though a slight tendency of a superior effectiveness is observed when using imri individually. Reported events: 11 patients in the 5a-imri group had re-operations. 8 patients in the 5a-imri group had an occurrence of a new neurologic deficit or worsening of preexisting deficit in the immediate postoperative period. 6 of these patients had these deficits remaining one month post-operatively. 1 patient in the 5a-imri group had superficial infection of the surgical wound. 1 patient in the 5a-imri group had meningitis (listeria). 1 patients in the 5a-imri group had an epidural hematoma.
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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
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key9492384
MDR Text Key184080606
Report Number1723170-2019-06089
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
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 Received12/09/2019
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: 12/19/2019 Patient Sequence Number: 1