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Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930)
Event Date 08/27/2021
Event Type  Injury  
Manufacturer Narrative
Patient age is the mean value of patients in the study. Patient gender is the majority value of patients in the study. Patient weight not available from the site. Event date is the online publish date of the article. Device lot number, or serial number, unavailable. 510(k) is dependent upon model number and is therefore unavailable. Device manufacture date is dependent on the device lot/serial number, therefore is unavailable. No parts have been received by the manufacturer for evaluation. If information is provided in the future, a supplemental report will be issued.
Event Description
Citation: albert m. Isaacs, chad g. Ball, nicholas sader, sandeep muram, david ben-israel, geberth urbaneja, jarred dronyk, richard holubkov, and mark g. Hamilton. Reducing the risks of proxumal and distal shunt failure in adult hydrocephalus: a shunt outcomes quality improvement study. J neurosurgery, 2021. Doi: 10. 3171/2021. 2. Jns202970. Abstract: objective: patient outcomes of ventriculoperitoneal (vp) shunt surgery, the mainstay treatment for hydrocephalus in adults, are poor because of high shunt failure rates. The use of neuronavigation or laparoscopy can reduce the risks of proximal or distal shunt catheter failure, respectively, but has less independent effect on overall shunt failures. No adult studies to date have combined both approaches in the setting of a shunt infection prevention protocol to reduce shunt failure. The goal of this study was to determine whether combining neuronavigation and laparoscopy with a shunt infection prevention strategy would reduce the incidence of shunt failures in adult hydrocephalic patients. Methods: adult patients (age
18 years) undergoing vp shunt surgery at a tertiary care institution prior to (pre¿shunt outcomes [shout]) and after (post-shout) the start of a prospective continuous quality improvement (qi) study were compared. Pre-shout patients had their proximal and distal catheters placed under conventional freehand approaches. Post-shout patients had their shunts inserted with neuronavigational and laparoscopy assistance in placing the distal catheter in the perihepatic space (falciform technique). A shunt infection reduction protocol had been instituted 1. 5 years prior to the start of the qi initiative. The primary outcome of interest was the incidence of shunt failure (including infection) confirmed by standardized criteria indicating shunt revision surgery. Results: there were 244 (115 pre-shout and 129 post-shout) patients observed over 7 years. With a background of shunt infection prophylaxis, combined neuronavigation and laparoscopy was associated with a reduction in overall shunt failure rates from 37% to 14%, 45% to 22%, and 51% to 29% at 1, 2, and 3 years, respectively (hr 0. 44, p < 0. 001). Shunt infection rates decreased from 8% in the pre-shout group to 0% in the post-shout group. There were no proximal catheter failures in the post-shout group. The 2-year rates of distal catheter failure were 42% versus 20% in the pre- and post-shout groups, respectively (p < 0. 001). Conclusions: introducing a shunt infection prevention protocol, placing the proximal catheter under neuronavigation, and placing the peritoneal catheter in the perihepatic space by using the falciform technique led to decreased rates of infection, distal shunt failure, and overall shunt failure. Reported events: nine shunt failures were noted to have been caused by an infection. Four shunt failures were noted to have been caused by overdrainage of cerebrospinal fluid (csf).
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key13045052
MDR Text Key283745702
Report Number1723170-2021-02924
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 12/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2021
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
Date Manufacturer Received11/29/2021
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: 12/20/2021 Patient Sequence Number: 1