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Model Number UNK_NAV_SYS
Device Problem Imprecision (1307)
Patient Problems Unspecified Infection (1930); Tissue Damage (2104)
Event Date 08/01/2017
Event Type  malfunction  
Manufacturer Narrative
Patient age is the mean value of the patients in the study. Patient gender is the majority value of the patients in the study. Device lot number, or serial number, unavailable. No parts have been received by the manufacturer for evaluation. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. Reported events 2-5 noted are adverse events that the product listed in section d did not cause or contribute to. 510(k) is not provided as the value is dependent on the device lot number/serial number. If information is provided in the future, a supplemental report will be issued.
Event Description
Citation: michael karsy, md, phd, hussam abou-al-shaar, md, christian a. Bowers, md, and richard h. Schmidt, md, phd. Treatment of idiopathic intracranial hypertension via stereotactic placement of biventriculoperitoneal shunts. Summary: objective idiopathicintracranial hypertension (iih), or pseudotumor cerebri, is a complex and difficult-to-manage condition that can lead to permanent vision loss and refractory headaches if untreated. Traditional treatment options, such as unilateral ventriculoperitoneal (vp) or lumboperitoneal (lp) shunt placement, have high complication and failure rates and often require multiple revisions. The use of bilateral proximal catheters has been hypothesized as a method to improve shunt survival. The use of stereotactic technology has improved the accuracy of catheter placement and may improve treatment of iih, with fewer complications and greater shunt patency time. Methods the authors performed a retrospective chart review for all patients with iih who underwent stereotactic placement of biventr iculoperitoneal (bvp) shunt catheters from 2008 to 2016 at their institution. Bilateral proximal catheters were y-connected to a strata valve with a single distal catheter. We evaluated clinical, surgical, and ophthalmological variables and outcomes. Results most patients in this series of 34 patients (mean age 34. 4 ± 8. 2 years, mean body mass index 38. 7 ± 8. 3 kg/m2; 91. 2% were women) undergoing 41 shunt procedures presented with headache (94. 1%) and visual deficits (85. 3%). The mean opening pressure was 39. 6 ± 9. 0 cm h2o. In addition, 50. 0% had undergone previous unilateral shunt placement, and 20. 6% had undergone prior optic nerve sheath fenestration. After bvp shunt placement, there were no cases of proximal catheter obstruction and only a single case of valve obstruction at 41. 9 months, with a mean follow-up of 24. 8 ± 20. 0 months. Most patients showed improvement in their headache (82. 4%), subjective vision (70. 6%), and papilledema (61. 5% preoperatively vs 20. 0% postoperatively, p
0. 02) at follow-up. Additional primary complications included 4 patients with migration of their distal catheters out of the peritoneum (twice in 1 patient), and an infection of the distal catheter after catheter dislodgment. The proximal obstructive shunt complication rate in this series (2. 9%) was lower than that with lp (53. 5%) or unilateral vp (37. 8%) shunts seen in the literature. Conclusions this small series suggests that stereotactic placement of bvp shunt catheters appears to improve shunt survival rates and presenting symptoms in patients with iih. Compared with unilateral vp or lp shunts, the use of bvp shunts may be a more effective and more functionally sustained method for the treatment of iih. Reported events: accusation of suboptimal accuracy because of excessive electromagnetic interference from metallic components in the operative field. One patient experienced a vp shunt malfunction due to a proximal obstruction. It was reported that the valve was replaced at 41. 9months after the procedure. One patient had a transected distal catheter during an unrelated abdominal surgery and required replacement. Two patients experienced a migration of the catheter outside of the peritoneum, resulting in an abdominal wall pseudocyst, where it was noted the issue occurred in the 1st post-operative month. One patient experienced a migration of the catheter outside of the peritoneum, resulting in an abdominal wall pseudocyst, where it was noted the issue occurred in the 16th post-operative month. Additionally, the patient had further complications due to the an abdominal wall infection after revision, requiring removal and replacement of the shunt system.
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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 Key9082188
MDR Text Key158995229
Report Number1723170-2019-04928
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 09/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received08/26/2019
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