MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLINE VLV W/ SPHNGRD; CERTAS PLUS W/ SG

Catalog Number 828805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Cerebral Ventriculomeglia (2133); Vomiting (2144)

Event Date 12/27/2021

Event Type  Injury  

Event Description

A facility reported that on (b)(6) 2021, a certas valve (ref.(b)(4)) was implanted in a (b)(6) year-old male patient due to internal occlusive post-inflammatory hydrocephalus.In the postoperative period there was an increase of the intracranial hypertension and the patient was experiencing headaches in the frontal region and vomiting.On (b)(6) 2021, x-ray computed tomography showed signs of an enlarged fourth ventricle, internal occlusive hydrocephalus, dislocation of the cerebellar tonsils into the foramen magnum.On (b)(6)2021 the patient underwent revision surgery: vp shunt revision, replacement of the programmable valve with ((b)(4)) with pressure level - setting 4.There was an improvement in patient's well-being after revision surgery.Cerebral symptoms regressed.

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

N/a.

Manufacturer Narrative

The certas valve was returned for evaluation: failure analysis - the valve was visually inspected; the needle guard was raised as well as a needle hole in the needle chamber.The valve was leak tested; only leaked from the needle hole in the needle chamber.The valve passed the tests for programming, occlusion, reflux, siphon guard and pressure.The needle chamber was dismantled; the needle guard was bent, and glue traces were noted on the needle guard and the silicone base.The root cause for the issue reported by the customer is probably due to the raised needle guard this is due to wrong handling as noted in the ifu: do not fold or bend the valve, folding or bending might cause rupture of the silicone housing, needle guard disc dislodgement or occlusion of the fluid pathway, at the time of investigation no functional issues were noted with the valve.

• Brand Name: CERTAS INLINE VLV W/ SPHNGRD
• Type of Device: CERTAS PLUS W/ SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13081443
• MDR Text Key: 288279283
• Report Number: 3013886523-2021-00566
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828805
• Device Lot Number: 3843835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Sex: Male