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

Catalog Number	42856
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	05/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned valve was patent.Therefore the conditions of this complaint could not be duplicated by laboratory personnel.The valve met the requirements for siphon testing.However, the valve did not meet the requirements for reflux, pressure-flow, and preimplantation testing.There was crystalline 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 and resulting in fluid 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.¿ the returned valve also did not meet the requirements for leak testing due to a tear observed in the top of the reservoir.It is unknown how or when this damage occurred.The ifu caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ the ifu also caution that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, or crushing of components.¿ a review of the manufacturing records showed no anomalies.All valves are 100% tested 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 distal part of the valve was not draining.According to the report, a revision of the shunt had to be done to replace it with another valve.Reportedly, the patient was stable.
Additional Manufacturer Narrative
The returned valve was patent.Therefore the conditions of this complaint could not be duplicated by laboratory personnel.The valve met the requirements for siphon testing.However, the valve did not meet the requirements for reflux, pressure-flow, and preimplantation testing.There was crystalline 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 and resulting in fluid 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.¿ the returned valve also did not meet the requirements for leak testing due to a tear observed in the top of the reservoir.It is unknown how or when this damage occurred.The ifu caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ the ifu also caution that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, or crushing of components.¿ a review of the manufacturing records showed no anomalies.All valves are 100% tested 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 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: 6658125
• Report Number: 2021898-2017-00338
• Device Sequence Number: 11115798
• Product Code: JXG
• UDI-Device Identifier: 00613994804631
• UDI-Public: 00613994804631
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup
• Report Date (Section B): 07/19/2017

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: 05/31/2018
• Device Catalogue Number: 42856
• Device Lot Number: D83521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 07/19/2017; 07/19/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 08/16/2017; 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