MAUDE Adverse Event Report: COVIDIEN LLC STRATA®; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2019

Event Type  Injury  

Event Description

Tsimiklis, c., mascarenhas, a., to, m.S., bishop, c.F., jenkinson, f., hunt, g., knight, n., harding, m., poonnoose, s.The nenefit of delayed reassessment post high-volume csf removal in the dianosis of shunt-responsive isiopathisc normal-pressure hydrocephalus.Journal of clinical neuroscience.2020 (71) 32-38.Https://doi.Org/10.1016/j.Jocn.2019.11.011.Abstract: the principle aim of the study was to demonstrate the value of performing delayed reassessment in the diagnosis of idiopathic normal -pressure hydrocephalus (inph) and selection of suitable candidates for ventriculoperitoneal shunting (vps).Thirty-one consecutive patients underwent thenph protocol at the flinders medical centre between march 2017 and november 2018.The p rotocol involved mobility and cognitive testing with reassessment post high-volume cerebrospinal fluid (csf) removal at 24h and 48h.The assessment of quality of life 6d (aqol-6d) questionnaire and international consultation on incontinence questionnaire ¿ urinary incontinence short form (iciq-ui sf) were completed and repeated again at 6 weeks and 6 months post shunting.Results were analysed to determine the significance of delayed reassessment.Twenty patients (64.5%) underwent insertion of a vps on the basis of objective improvements and specific criteria.Of these, 6 patients (30%) were shunted based on delayed reassessment at 48 h post csf removal.Continued improvements were seen for all mobility and cognitive tests from baseline to 48 h post csf removal.At 6 weeks and 6 months post shunting, there was an overall mean improvement in aqol-6d and iciq-ui sf for the cohort and the improvement was also observed in the subgroup of patients who met shunt criteria at 48 h post csf removal.In the diagnosis of shunt-responsive idiopathic normal-pressure hydrocephalus, delayed reassessment post csf removal improves sensitivity and is therefore important reported events one of these patients also required subsequent revision of the distal catheter due abdominal adhesions.

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patient in the study.Patient weight not available from the site.Event date is the accepted date of the literature article.Device lot number, or serial number, unavailable.510(k) is dependent upon the device model number and therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.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): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14270298
• MDR Text Key: 292586851
• Report Number: 9612501-2022-00707
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 72 YR
• Patient Sex: Male