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 Urinary Tract Infection (2120)

Event Date 07/24/2020

Event Type  malfunction  

Event Description

Raygor, k.P., oh, t., hwang, j.Y., phelps, r.R.L., ghoussaini, k., wong, p., silvers, r., ostling, l.R., sun, p.P.Ventriculoperitoneal shunt infection rates using a standard surgical technique, including topical and intraventricular vancomycin: the (b)(6) experience.J neurosurg pediatr 2020.(26) 504¿512.Doi: 10.3171/2020.4.Peds209.Objective ventriculoperitoneal (vp) shunt infections are common complications after shunt operations.Despite the use of intravenous antibiotics, the incidence of infections remains high.Though antibiotic-impregnated catheters (aics) are commonly used, another method of infection prophylaxis is the use of intraventricular (ivt) antibiotics.The authors describe their single-institution experience with a standard shunt protocol utilizing prophylactic ivt and topical vancomycin administration and report the incidence of pediatric shunt infections.Methods three hundred two patients undergoing vp shunt procedures with ivt and topical vancomycin between 2006 and 2016 were included.Patients were excluded if their age at surgery was greater than 18 years.Shunt operations were performed at a single institution following a standard shunt protocol implementing ivt and topical vancomycin.No aics were used.Clinical data were retrospectively collected from the electronic health records.Results over the 11-year study period, 593 vp shunt operations were performed with ivt and topical vancomycin, and a total of 19 infections occurred (incidence 3.2% per procedure).The majority of infections (n = 10, 52.6%) were caused by staphylococcus epidermidis.The median time to shunt infection was 3.7 weeks.On multivariate analysis, the presence of a csf leak (or 31.5 [95% ci 8.8¿112.6]) and age less than 6 months (or 3.6 [95% ci 1.2¿10.7]) were statistically significantly associated with the development of a shunt infection.A post hoc analysis comparing infection rates after procedures that adhered to the shunt protocol and those that did not administer ivt and topical vancomycin, plus historical controls, revealed a difference in infection rates (3.2% vs 6.9%, p = 0.03).Conclusions the use of a standardized shunt operation technique that includes ivt and topical vancomycin is associated with a total shunt infection incidence of 3.2% per procedure, which compares favorably with the reported rates of shunt infection in the literature.The majority of infections occurred within 2 months of surgery and the most common causative organism was s.Epidermidis.Young age (6 months) at the time of surgery and the presence of a postoperative csf leak were statistically significantly associated with postoperative shunt infection on multivariate analysis.The results are hypothesis generating, and the authors propose that ivt and topical administration of vancomycin as part of a standardized shunt operation protocol may be an appropriate option for preventing pediatric shunt infections.Reportable events: 17 cases (2.9%) of postoperative csf leak not all required shunt revision 3 others developed urinary tract infections that required a standard antibiotic course.

Manufacturer Narrative

Patient age not available from the site.Patient gender is the majority value of patient in the study.Patient weight not available from the site.Event date is the online publishing 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: 14221268
• MDR Text Key: 290273812
• Report Number: 9612501-2022-00686
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 04/19/2022
• 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 Sex: Male