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

Catalog Number 42955

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

Patient Problems Fatigue (1849); Headache (1880); Seizures (2063); Vomiting (2144); Therapeutic Response, Decreased (2271); Loss of consciousness (2418)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

The returned valve was patent.Therefore the conditions of the complaint could not be duplicated by laboratory personal.The valve met the requirements for siphon, reflux, pressure-flow, and pre-implantation testing.The valve did not meet requirements for leak testing due to a tear in the top of the reservoir.It is unknown how or when this damage occurred.The instructions for use (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 was not possible as no lot number was provided.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 in (b)(6) 2016.According to the report, in late (b)(6) there was no flow through the valve and there was no grossly visible deformity or debris.The valve was replaced with a new valve that worked normally and there was no injury to the patient.

Manufacturer Narrative

Additional information received reported the patient had underwent 4 single shot mris prior to explant.According to the report, imaging showed an enlargement of the patient¿s ventricles.It was also stated that the patient had been kicked in the head.Device information provided.Implant date provided.A review of the manufacturing records showed no anomalies.

Manufacturer Narrative

Additional information received reported the patient underwent two mris while the device was implanted.The valve had also been adjusted from 2.0 to 1.5 on (b)(6) 2016.Reportedly, the patient was ¿acute¿ prior to having the valve revised.It was also noted the valve was primed with a solution of bacitracin and saline at 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.

Manufacturer Narrative

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

Event Description

Additional information received reported that the patient was seen on (b)(6) 2016, complaining of headaches and seizures.The doctor performed a shunt tap to assess malfunction and attempted to reprogram their shunt.Mri revealed increased ventricle size indicating underdrainage of cerebrospinal fluid.On (b)(6) 2016, the patient again presented with symptoms of underdrainage.3 weeks prior, the patient experienced a kick to the head overlying their shunt valve with later development of headache and vomiting that progressed to prolonged seizures.Per the patient's mother, they administered midazolam and clonidine at home which aborted the seizure, but they did not return to their neurological baseline.A mri was performed in the emergency room that demonstrated overall enlargement of the bilateral ventricular system with unchanged positioning of the left parietal approach ventricular catheter.On examination, they were noted to be sleepy and unresponsive to verbal command.The patient was noted to have additional seizures in the emergency department with asymmetric appearance of their pupils.Aspiration under sterile conditions of their left parietal approach ventriculoperitoneal shunt revealed clear cerebrospinal fluid with spontaneous flow under moderate pressure, 10ml of which were removed and sent to the laboratory.The doctor recommended a shunt revision.During the revision, the doctor disconnected the ventricular catheter from the valve and found that the catheter drained spontaneously clear cerebrospinal fluid under a significant amount of pressure.The doctor proceeded to connect the manometer to the proximal end of the valve using a small piece of tubing and found no evidence of spontaneous flow through the valve and peritoneal catheter.They gently flushed through the valve and again found no evidence of flow through the manometer system into the valve and peritoneal catheter.The doctor then removed the existing valve and connected the manometer to the peritoneal catheter itself.The sterile saline then flowed into the peritoneum down to a level of -5 cm of water, consistent with a patent peritoneal catheter system and confirming the diagnosis of a valve malfunction.

Manufacturer Narrative

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

• Brand Name: STRATAMR VALVE, SMALL
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6197392
• MDR Text Key: 63049140
• Report Number: 2021898-2016-00481
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K152700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 42955
• Device Lot Number: E13641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1702-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 12 YR