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

Model Number UNKNOWN-S

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

Patient Problems Bacterial Infection (1735); Cerebrospinal Fluid Leakage (1772); Pneumonia (2011); Urinary Tract Infection (2120); Respiratory Failure (2484); Convulsion/Seizure (4406)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Kunal p.Raygor, taemin oh, joan y.Hwang, ryan r.L.Phelps, kristen ghoussaini, patrick wong, rebecca silvers, lauren r.Ostling, and peter p.Sun.Ventriculoperitoneal shunt infection rates using a standard surgical technique, including topical and intraventricular vancomycin: the children¿s hospital oakland experience.Journal of neurosurgery pediatrics 26 (2020).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 me thod 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 incidenceof 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.Reported events.- there were 17 cases of postoperative csf leak, though not all of these patients required shunt revision.- 19 postoperative shunt infections occurred in cases that adhered to the study protocol with topical and ivt vancomycin.The majority (52.6%, n = 10) of shunt infections were caused by coagulase-negative s.Epidermidis.The remaining infections were caused by enterococcus faecalis and escherichia coli (n = 2), e.Coli alone (n = 1), proteus mirabilis (n = 1), peptostreptococcus asaccharolyticus (n = 1), pseudomonas aeruginosa (n= 3), and a severe case of rotavirus enterocolitis (n = 1).Csf cultures were positive in all patients deemed to have a shunt infection, except the patient with rotavirus enterocolitis (94.7% culture positivity).There was one case of abdominal pseudocyst associated with s.Epidermidis csf infection.- there were 23 adverse events.Fifteen adverse events involved the development of postoperative red man syndrome (rms), though in some cases due to penicillin allergies, patients also received intravenous vancomycin, so it was not obvious whether the intravenous or ivt vancomycin was the cause in those cases.All cases of rms involved mild pruritis and were treated with intravenous diphenhydramine only.There were no cases of anaphylaxis.Two patients developed acute respiratory failure due to pneumonia in the perioperative period, requiring prolonged intubation and antibiotics, and 3 others developed urinary tract infections that required a standard antibiotic course.Two patients had postoperative seizures treated with antiepileptic medication; neither patient had a preoperative seizure history.Finally, one patient developed transient diabetes insipidus that was treated with desmopressin administration until sodium homeostasis was achieved.- 12 shunt infections were observed in which topical or ivt vancomycin was not used.See attached literature article.

• Brand Name: UNKNOWN STRATA VALVE/SHUNT
• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 11032912
• MDR Text Key: 223617004
• Report Number: 2021898-2020-00366
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/14/2020
• 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