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

Model Number 42866

Device Problems Inaccurate Flow Rate (1249); Mechanics Altered (2984)

Patient Problems Vomiting (2144); Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that prior to the implant of the shunt, the patient experienced syncope and was hospitalized in early (b)(6) 2012.A few days after the syncope, they underwent tumor resection with a suboccipital approach.The patient had a ventriculoatrial shunt installed by the end of (b)(6) 2012.A few years later, in late (b)(6) 2016, the patient¿s brain tumor recurred.They underwent tumor resection in early (b)(6) and the pressure level (pl) setting of the valve was set to 0.5.The patient experienced vomiting, unstable walking, and was unresponsive in (b)(6) 2017.The patient was admitted with the pl setting still at 0.5.It was stated that 200-300 ml of cerebrospinal fluid was drained from the patient and their symptoms improved.In late (b)(6) , the patient had exploratory surgery and after the operation was better, however would soon regress.It was noted the patient repeatedly had mris done following surgery and could not reach the same drainage effect as experienced prior to the mri.The doctor questioned whether the valve was damaged.The shunt was removed and replaced.

Manufacturer Narrative

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

Manufacturer Narrative

The returned valve was patent.It met the requirements for siphon, and pre-implantation testing.The valve did not meet the requirements for reflux and 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 multiple tears 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.All valves are 100% tested at the time of manufacture.Upon review of the analysis results, it was determined that eval code conclusion 92 no longer applies.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a health care provider (hcp) via a manufacturer representative (rep).It was confirmed that the valve settings were changed after the mri.

• Brand Name: STRATA II 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 55432 ; 7635260594
• MDR Report Key: 7064344
• MDR Text Key: 93113664
• Report Number: 2021898-2017-00609
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: 42866
• Device Catalogue Number: 42866
• Device Lot Number: D23189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2012
• 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: 24 YR