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

Model Number	92856
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	11/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the device was occluded and explanted.The patient's current status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for siphon, pressure flow, and preimplantation testing.However, the device did not meet requirements for leak and reflux testing due to a tear observed in the top of the delta chamber.It is unknown how or when this damage occurred.The ifu cautions that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ the ifu also cautions that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, crushing or breaking of components.¿ 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, 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: 7075438
• Report Number: 2021898-2017-00621
• Device Sequence Number: 13792463
• Product Code: JXG
• UDI-Device Identifier: 00643169010420
• UDI-Public: 00643169010420
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042465
• 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
• Report Date (Section B): 02/07/2018

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: 07/31/2019
• Device Model Number: 92856
• Device Catalogue Number: 92856
• Device Lot Number: E15394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 02/07/2018
• 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