MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS RA SG VLV ONLY; CERTAS PLUS SMALL & RA W/SG

Catalog Number 828824

Device Problem Obstruction of Flow (2423)

Patient Problem Injury (2348)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

This is 3 of 5 reports.Background: a (b)(6)-year-old male had a valve implanted (non-integra) on an unknown date.The valve was revised due to increased ventricle size on ct and fractured shunt showed on x-ray.At procedure, the old shunt was disconnected, a temporary catheter was connected due to catheter fracture and valve was confirmed as blocked with no csf egress.On (b)(6) 2020, a certas right angled valve was implanted (ref 828824 lot 4436813).On (b)(6) 2020 (1st revision), the certas valve (ref 828824 lot 4436813) was found to be blocked and was removed.The valve was not replaced with another valve: a rickham reservoir (ref 821623 lot 3711879) was inserted to allow access for csf testing and icp monitoring.A procedure for endoscopic third ventriculostomy was performed.On (b)(6) 2020, the patient had a surgery to insert a new certas valve (ref 828824 lot 4936170) and bactiseal ventricular catheter (ref 823073 lot 440595) and bactiseal ventricular and peritoneal catheter kit (ref 823072 lot# 4407195) were also inserted.On (b)(6) 2020, (2nd revision) the certas valve (ref 828824 lot 4936170) was found to be blocked.A ventriculoperitoneal (vp) shunt revision was performed and the valve was replaced with a new certas valve (ref 828824 lot 4837586) with setting of 4.On (b)(6) 2020, (3rd revision) the certas valve (ref 828824 lot 4837586) that was implanted on november 16, 2020 with a setting of 4 was found to be blocked.A new certas valve (ref 828824 lot 4123593) was placed with a setting of 3.On (b)(6) 2020, (4th revision) the certas valve that was implanted on (b)(6) 2020 (ref 828824 lot 4123593) appears blocked and the abdominal catheter was not flowing.The valve was revised with hakim valve and the valve was set at 90mmh.Also, the catheter kit implanted on november 11 (ref 823072 lot 4407195) was not flowing and was replaced with bactiseal ventricular and peritoneal catheter kit 823072 lot# 4451774.Each time the patient has a valve revision, he had an initial improvement of symptoms for a couple of days after insertion.Other mfg report no.: 3013886523-2020-00251, 3013886523-2020-00249, 3013886523-2020-00247, and 3013886523-2020-00248.

Manufacturer Narrative

Unique device identifier (udi) : (b)(4).The valve was not returned for evaluation (as per customer, product not available) therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.The possible root cause for ¿certas valve was found to be blocked¿ could be due to biological debris and protein build up that may cause an occlusion.

Manufacturer Narrative

Additional information received: question sent to the facility: do they (medical staff) think the occlusions are a consequence of biological material buildup i.E., clot having resulted from the bleeding from the etv procedure? answer: "regarding biological material buildup: definitely not blood as the etv was quite clean and blockages were happening before the etv too.The only thing was that his protein count was slightly elevated (between 1.18/l to 2.06g/l over six measurements in november)".

Event Description

N/a.

• Brand Name: CRTS RA SG VLV ONLY
• Type of Device: CERTAS PLUS SMALL & RA W/SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11031711
• MDR Text Key: 222290462
• Report Number: 3013886523-2020-00250
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828824
• Device Lot Number: 4936170
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR