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

Model Number UNKNOWN-S

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Seroma (2069); Unspecified Nervous System Problem (4426)

Event Date 11/23/2018

Event Type  Injury  

Event Description

Citation: outcomes and complications of different surgical treatments for idiopathic normal pressure hydrocephalus: a systematic review and me ta-analysis https://thejns.Org/doi/abs/10.3171/2018.5.Jns1875.Summary: objective: different csf diversion procedures (ventriculoperitoneal, ventriculoatrial, and lumboperitoneal shunting) have been utilized for the treatment of idiopathic normal pressure hydrocephalus.More recently, endoscopic third ventriculostomy has been suggested as a reasonable alternative in some studies.The purpose of this study was to perform a systematic review and meta-analysis to assess overall rates of favorable outcomes and adverse events for each of these treatments.An additional objective was to determine the outcomes and complication rates in relation to the type of valve utilized (fixed vs programmable).Methods: multiple databases (pubmed, ovid medline in-process & other non-indexed citations, ovid medline, ovid embase, ovid cochrane central register of controlled trials, ovid cochrane database of systematic reviews, and scopus) were searched for studies involving patients with idiopathic ventriculomegaly, no secondary cause of hydrocephalus, opening pressure 25 mm hg on high-volume tap or drainage trial, and age > 60 years.Outcomes included the proportion of patients who showed improvement in gait, cognition, and bladder function.Adverse events considered in the analysis included postoperative ischemic/hemorrhagic complications, subdural fluid collections, seizures, need for revision surgery, and infection.Results: a total of 33 studies, encompassing 2461 patients, were identified.More than 75% of patients experienced improvement after shunting, without significant differences among the different techniques utilized.Overall, gait improvement was observed in 75% of patients, cognitive function improvement in more than 60%, and improvement of incontinence in 55%.Adjustable valves were associated with a reduction in revisions (12% vs 32%) and subdural collections (9% vs 22%) as compared to fixed valves.Conclusions: outcomes did not differ significantly among different csf diversion techniques, and overall improvement was reported in more than 75% of patients.The use of programmable valves decreased the incidence of revision surgery and of subdural collections after surgery, potentially justifying the higher initial cost associated with these valves.Reported event(s): the article as a retrospective and prospective analysis of studies that occurred from 1975-november 2017.The studies documented data from 2,461 patients total, 1,412 of which underwent vp shunting with a medtronic device.Patients were >60 years of age, with a mean/median age of >70 years.Patient sex information was not provided.Complication rates for patients treated with vp shunts ranged from 13-38%, the majority occurring within the first year after surgery.Postoperative ischemic or hemorrhagic complications were reported in 2% of patients.Postoperative infection rates were 3%.Surgical revision was performed in 18% patients, with a mean follow-up time of 3-78 months.Postoperative subdural hematomas or hygromas after vp shunt placement in 10% of patients.It was estimated that 20-33% of patients treated with vp shunts required additional surgery.15% underwent shunt revision during a 1 year period.Infection was considered the second most common complication, with a prevalence of 3-12%.Permanent neurological deficits from significant intercranial hemorrhage or ischemic events were noted to be uncommon, with a prevalence or 1-6%.The risk of intraparenchymal hematoma from ventricular catheter placement was estimated to be approximately 1%.Approximately 40% of patients had symptoms of overdrainage.Most of these patients were treated with shunt reprogramming.The type of shunt in the patients that experienced overdrainage was not specified.

Manufacturer Narrative

No products have been returned to medtronic for analysis.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA®
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15028927
• MDR Text Key: 295979298
• Report Number: 2021898-2022-00156
• 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: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Device Lot Number: -
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 70 YR