MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATAMR VALVE, SMALL; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	42955
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	02/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for siphon, reflux, and pre-implantation testing.The valve did not meet the requirements for pressure-flow 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 reflux and affecting the flow of fluid through the valve.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.¿ the returned valve also did not meet the requirements for leak due to a tear in the top of the reservoir.It is unknown how or when this damage occurred.The ifu caution that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, or crushing of components.¿ the ifu also caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that the device stopped draining.According to the report, the device was explanted and there was no injury.
Additional Manufacturer Narrative
Additional information received reported the patient had undergone an mri and adjustment.In addition, the valve had been soaked in bacitracin prior to implant.A good faith effort will be made to obtain the applicable information relevant to the report.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: STRATAMR VALVE, SMALL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6390023
• Report Number: 2021898-2017-00090
• Device Sequence Number: 10900298
• Product Code: JXG
• UDI-Device Identifier: 00643169692718
• UDI-Public: 00643169692718
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2017

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: 42955
• Device Lot Number: E12556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: Not provided; 03/31/2017
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 04/28/2017; 10/02/2017
• 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: 32 MO
• Patient Weight: 11