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

Catalog Number 42365

Device Problems Break (1069); Inaccurate Flow Rate (1249); Appropriate Term/Code Not Available (3191)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 03/17/2017

Event Type  Injury  

Manufacturer Narrative

The product was unavailable for return.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.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 Description

It was reported to medtronic neurosurgery that the device was implanted due to hydrocephalus on (b)(6) 2017.According to the report, on the day following implant, the device showed poor drainage.The patient had an x-ray which showed that the reservoir was damaged.Reportedly, the device was replaced on (b)(6) and the patient¿s status was well.

Manufacturer Narrative

The returned valve was patent.The valve met the requirements for siphon testing.However, the device did not meet the requirements for reflux, pressure-flow and preimplantation 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.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 valve did not meet requirements for leak testing due to multiple tears in the top of the reservoir.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.¿ a review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis results updated the returned valve was patent.The valve met the requirements for reflux testing.However, the valve did not meet the requirements for pressure-flow, and pre-implantation testing.There was 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 (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 valve did not meet the requirements for leak testing due to a tear observed in the side of the reservoir.It is unknown how or when this damage occurred.The instructions for use (ifu) that accompany the device caution 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.Due to imdrf harmonization, the device, method, result, and conclusion codes have been updated.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA NSC VALVE, REGULAR
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis,mn, CA 55432 ; 7635260594
• MDR Report Key: 6504430
• MDR Text Key: 73186034
• Report Number: 2021898-2017-00207
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169466111
• UDI-Public: 00643169466111
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K033850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 42365
• Device Lot Number: E10786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2017
• Initial Date FDA Received: 04/19/2017
• Supplement Dates Manufacturer Received: Not provided; 05/15/2017; 07/05/2018; 08/08/2018
• Supplement Dates FDA Received: 06/14/2017; 10/03/2017; 07/24/2018; 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR