MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II VALVE, BURR HOLE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	42836
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient¿s underlying disease symptoms were not improved.A shunt angiogram was performed and occlusion was suspected.Cerebrospinal fluid (csf) did not flow from the valve to the abdominal catheter.Although the performance level was set to 0.5, the csf did not flow without applying the pressure 10 cm.The valve was replaced.It was stated there was a malfunction of the ¿variant part¿ of the valve.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received clarified that the ¿variant part¿ of the valve referred to the valve mechanism.
Additional Manufacturer Narrative
The returned valve was patent.The valve also met the requirements for pressure-flow, preimplantation and leak testing.However, the device did not meet the requirements for reflux and siphon testing.There was proteinaceous debris observed within the interior and exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open resulting in fluid siphoning and reflux.The instructions for use (ifu) 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.¿ all valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA II VALVE, BURR HOLE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7176213
• Report Number: 2021898-2018-00017
• Device Sequence Number: 1888356
• Product Code: JXG
• UDI-Device Identifier: 00643169975811
• UDI-Public: 00643169975811
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2018

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: 04/30/2020
• Device Model Number: 42836
• Device Catalogue Number: 42836
• Device Lot Number: E34280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 01/24/2018; 03/01/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 02/15/2018; 03/06/2018
• 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