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

Model Number UNKNOWN-S

Device Problem Complete Blockage (1094)

Patient Problems Bacterial Infection (1735); Meningitis (2389); Post Operative Wound Infection (2446)

Event Date 06/24/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Joona tervonen, hadie adams, antti lindgren, antti-pekka elomaa, olli-pekka kämäräinen, virve kärkkäinen, mikael von und zu fraunberg, jukka huttunen, timo koivisto, juha e.Jääskeläinen, ville leinonen, terhi j.Huuskonen.Shunt performance in 349 patients with hydrocephalus after aneurysmal subarachnoid hemorrhage.Acta neurochirurgica (2021).Doi: 10.1007/s00701-021-04877-1 abstract background shunt-dependent hydrocephalus after aneurysmal subarachnoid hemorrhage (asah) is a common sequelae leading to poorer neurological outcomes and predisposing to various complications.Methods a total of 2191 consecutive patients with asah were acutely admitted to the neurointensive care at the kuopio university hospital between 1990 and 2018 from a defined population.A total of 349 (16%) asah patients received a ventriculoperitoneal shunt, 101 with an adjustable valve (2012¿2018), 232 with a fixed pressure valve (1990¿2011), and 16 a valveless shunt (2010¿2013).Clinical timelines were reconstructed from the hospital records and nationwide registries until death (n = 120) or june 2019.Results comparing the adjustable valves vs.The fixed pressure valves vs.The valveless shunts, intraventricular hemorrhage was present in 61%, 44% and 100%, respectively.The median times to the shunt were 7 days vs.38 days vs.10 days.The rates of the first revision were 25% vs.32% vs.69%.The causes included infection in 11% vs.7% vs.25% and overdrainage in 1% vs.4% vs.31%.The valveless shunt was the only independent risk factor (hr 2.9) for revision.After the first revision, more revisions were required in 48% vs.52% vs.45%.Conclusions the protocol to shunt evolved over time to favor earlier shunt.In post-asah hydrocephalus, adjustable valve shunts, without anti-siphon device, can be installed at an early phase after asah, in spite of intraventricular blood, with a modest risk (25%) of revision.Valveless shunts are not recommendable due to high risk of revisions.Reported events: - shunt revision was required in 25 (25%) of the 101 patients, until death (n = 5) or june 2019, in a median time of 7 days since shunt insertion.The cumulative rate for the first revision was 14% at 1 month and 23% at 1 year.Of the 25 patients with shunt revision, nine had previous valve adjustments.In overall, multiple (two or more) revisions were required in 12 (48%) of the 25 revised patients.Shunt infection (n = 11) was the most common cause for shunt revision, in a median of 5 days.All 11 patients had evd and i.V.Cefuroxime prophylaxis since the shunt installation.Ten patients had clinical meningitis, including decreased csf glucose, and one had a wound infection.However, bacterial cultures remained negative, except in two cases (staphylococcus warneri and staphylococcus aureus) considered possible contaminations.The pcr testing of csf samples was not performed.The infections somewhat clustered in the early shunts.Valve occlusion (n = 8) was the second most common reason for shunt revision, in a median of 12 days.The 15 s hunts with the anti-siphon device were installed in a median of 39 days (iqr 8¿220), and only one of them occluded.The 86 shunts without the anti-siphon device were installed much earlier, in a median of 7 days (iqr 5¿11), and seven of them occluded.

• 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12295931
• MDR Text Key: 266232860
• Report Number: 2021898-2021-00146
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• 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: 07/30/2021
• 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