MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-S

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 02/02/2018

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided.Sex: please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided.Date of event: please note that this date is based off the date of publication of the article as the actual event date was not provided.If information is provided in the future, a supplemental report will be issued.

Event Description

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 biventriculo-peritoneal shunts.Journal of neurosurgery 130 (2019).Doi: 10.3171/2017.8.Jns162927.Objective: idiopathic intracranial 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 biventriculo-peritoneal (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 w omen) 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: 5 patients (14.7%) required additional shunt related surgery.Of the 34 patients who underwent bvp shunt placement, 3 patients had 1 revision and 2 patients had 2 revisions, resulting in 41 total shunt placements.Of these, only 1 patient¿s (2.9%) vp shunt malfunction was due to a proximal obstruction.In this case, an obstructed valve was replaced 41.9 months after initial placement, but the proximal catheter was found to be patent.Four patients underwent revision of their distal peritoneal catheter.In 1 patient, the distal catheter was transected during unrelated abdominal surgery and required replacement.The other 3 patients had migration of the catheter out of the peritoneum, causing an abdominal wall pseudocyst.All except one occurred initially within the 1st postoperative month.Migration of the catheter occurred a second time in 1 patient at 16 months.In another of these patients, the repair was further complicated by an abdominal wall infection after revision, requiring removal and eventual replacement of the entire shunt system.

• Brand Name: UNKNOWN STRATA VALVE/SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8650304
• MDR Text Key: 146380993
• Report Number: 2021898-2019-00208
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 34 YR