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

Model Number UNKNOWN-S

Device Problems Fluid/Blood Leak (1250); Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Hematoma (1884); Hemorrhage, Subdural (1894); Unspecified Infection (1930); Seroma (2069); Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: unknown-a, serial/lot #: unknown.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.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Eduardo orrego-gonzález, alejandro enriquez-marulanda, luis c.Ascanio, noah jordan, khalid a.Hanafy, justin m.Moore, christopher s.Ogilvy, ajith j.Thomas.A cohort comparison analysis of fixed pressure ventriculoperitoneal shunt valves with programmable valves for hydrocephalus following nontraumatic subarachnoid hemorrhage.Operative neurosurgery 0 (2019).Doi: 10.1093/ons/opz195.Background: hydrocephalus after nontraumatic subarachnoid hemorrhage (sah) is a common sequela that may require the placement of ventriculoperitoneal shunts (vps).Adjustable-pressure valves (apvs) are being widely used in this situation though more expensive than differential-pressure valves (dpvs).Objective: to compare outcomes between apv and dpv in sah-induced hydrocephalus.Methods: we performed a retrospective chart review of patients with nontraumatic sah who underwent vps placement for the treatment of hydrocephalus after sah, between july 2007 and december 2016.Patients were classified according to the type of valve (apv vs dpv).We evaluated factors that could predict the type of valve used, outcomes in vps revision/replacement rate, and complications.Results: a total of 66 patients underwent vps placement who were equally distributed into the 2 groups of valves.Vps failure with the need for revision/replacement occurred in 13 (19.7%) cases.Ten (30.3%) patients with dpv had a vps failure, while 3 (9.1%) patients with an apv had a similar failure with the need for revision/replacement (p =.03).Vps placement before discharge during the initial hospitalization(p =.02) was statistically significant associated with the use of a dpv, while the reason of external ventricular drain (evd) failure (p =.03) was associated with the use of an apv.Conclusion: apvs had a lower rate of surgical revisions compared to dpvs.Early placement of vps was associated with the use of a dpv.The need for evd replacement due to evd infection or malfunction was associated with higher rates of apv use.Reported events.- most patients (69.7%) had a good functional outcome at last clinical follow-up.Thirteen (19.7%) patients required a vps revision with subsequent replacement of 1 or more of the components of the vps system.Proximal catheter replacement was recorded in 5 (7.6%) cases, distal catheter in 7 (10.6%) cases, and valve replacement in 12 (18.2%) cases.The reasons for replacement of 1 or more of the vps system components was due to infection (n = 4; 30.8%), obstruction (n = 4; 30.8%), overdrainage (n = 2; 15.3%), underdrainage (n = 1; 7.7%), shunt hardware exposure (n = 1; 7.7%), and shunt malposition(n = 1; 7.7%).The reasons for valve replacement recorded in the dpv group (n=10) were obstruction in 2 cases, infection in 4 cases, overdrainage in 2 cases, underdrainage and enlarged ventricles in 1 case (underwent surgical revision and replacement with an apv), and shunt exposure in 1 case.With the 2 overdrainage cases, 1 patient experienced a hygroma and the other case complained of headaches refractory to medical therapy.Both cases were revised and replaced with an apv.For the apv group, there were only 2 cases with a valve replacement performed and the reason in 1 case was obstruction, and in the other one was misplacement.1 patient in the apv group experienced a subdural hematoma (sdh) due to overdrainage.The patient was treated with a pressure level adjustment in which it was changed from 0.5 to 2.5.

• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 9246276
• MDR Text Key: 178762694
• Report Number: 2021898-2019-00382
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 10/28/2019
• 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: 59 YR