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 Problem Unspecified Infection (1930)

Event Date 12/22/2021

Event Type  Injury  

Manufacturer Narrative

B3.Please note that this date is based off the date of publication of the article as the actual event date was not provided.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.

Event Description

Peter y.M.Woo, desiree k.K.Wong, yixuan yuan, xiaoqing guo, michael k.W.See, matthew tam, alain k.S.Wong, kwong-yau chan.A morphometric analysis of commonly used craniometric approaches for freehand ventriculoperitoneal shunting.Operative neurosurgery 22 (2022).Doi: 10.1227/ons.0000000000000047 background: ventricular catheter tip position is a predictor for ventriculoperitoneal shunt survival.Cannulation is often performed freehand, but there is limited consensus on the best craniometric approach.Objective: to determine the accuracy of localizing craniometric entry sites and to identify which is associated with optimal catheter placement.Methods: this is a retrospective analysis of adult patients who underwent ventriculoperitoneal shunting.The approaches were categorized as kocher¿s, keen¿s, frazier¿s and dandy's points as well as the parieto-occipital point.An accurately sited burr hole was within 10mmfromstandard descriptions.Optimal catheter tip position was defined as within the ipsilateral frontal horn.Results: a total of 110 patients were reviewed, and 58% (65/110) of burr holes were accurately sited.Keen¿s point was the most correctly identified (65%, 11/17), followed by kocher¿s point (65%, 37/57) and frazier's point (60%, 3/5).Predictors for accurate localization were keen¿s point (odds ratio 0.3; 95% ci: 01-0.9) and right-sided access (odds ratio 0.4; 95% ci: 0.1-0.9).Sixty-three percent (69/110) of catheters were optimally placed with keen¿s point (adjusted odds ratio 0.04; 95% ci: 0.01-0.67), being the only independent factor.Thirteen patients (12%) required shunt revision at a mean duration of 10 ± 25 mo.Suboptimal catheter tip position was the only independent determinant for revision (adjusted odds ratio 0.11; 95% ci: 0.01-0.98).Conclusion: this is the first study to compare the accuracy of freehand ventricular cannulation of standard craniometric entry sites for adult patients.Keen¿s point was the most accurately sited and was a predictor for optimal catheter position.Catheter tip location, not the entry site, predicted shuntsurvival.Reported events.- 3 patients experienced infection and 2 patients experienced overshunting which required shunt revision.

• 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: 18527512
• MDR Text Key: 333048239
• Report Number: 2021898-2024-00056
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• 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: 01/12/2024
• 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): Required Intervention