MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II SHUNT ASSEMBLY, SMALL, WITH BIOGLIDE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	27818
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	05/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for siphon, reflux, and leak testing.However, it did not meet the requirements for pressure flow and preimplantation testing.There was proteinaceous debris noted within the interior and exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open affecting the flow of fluid through the valve.The instructions for use that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system.The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization or other debris¿.Approximately 58 cm of the peritoneal catheter was returned.It met the requirements for patency and leak testing.Proteinaceous debris was observed within the interior and exterior of the catheter.Approximately 16 cm of the ventricular catheter was returned.It met the requirements for patency and leak testing.Proteinaceous debris was observed within the interior and exterior of the catheter.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.All catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to medtronic neurosurgery that the patient had shunt surgery due to hydrocephalus.According to the report, after the device was implanted, excessive drainage occurred along with the magnetic resonance imaging examination showed small ventricles.Reportedly, the device was replaced with another one, and the patient's status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for siphon, reflux, and leak testing.However, it did not meet the requirements for pressure flow and preimplantation testing.There was proteinaceous debris noted within the interior and exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open affecting the flow of fluid through the valve.The instructions for use that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system.The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization or other debris¿.Approximately 58 cm of the peritoneal catheter was returned.It met the requirements for patency and leak testing.Proteinaceous debris was observed within the interior and exterior of the catheter.Approximately 16 cm of the ventricular catheter was returned.It met the requirements for patency and leak testing.Proteinaceous debris was observed within the interior and exterior of the catheter.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.All catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA II SHUNT ASSEMBLY, SMALL, WITH BIOGLIDE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6674195
• Report Number: 2021898-2017-00351
• Device Sequence Number: 16615112
• Product Code: JXG
• UDI-Device Identifier: 00643169010505
• UDI-Public: 00643169010505
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 27818
• Device Lot Number: E12417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 07/17/2017; 07/17/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 08/15/2017; 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 6 MO