MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV ONLY W/SPHNGD; CERTAS PLUS W/ SG

Catalog Number 828804

Device Problem Output Problem (3005)

Patient Problem Injury (2348)

Event Date 11/25/2020

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

A physician reported the inability to program a shunt post implantation that occurred on (b)(6) 2020.A certas plus valve was placed via ventricular peritoneal shunt on (b)(6) 2019 with an initial setting of 7 mmhg.At the same time, an endoscopic third ventriculostomy was also performed.The patient¿s symptoms reportedly improved.On (b)(6) 2020, the patient had transient sleep apnea syndrome.On (b)(6) 2020, the patient presented to the hospital and was admitted to the hospital for possible obstruction of the endoscopic third ventriculostomy.The provider attempted to change the valve setting from 6 mmhg to 5 mmhg unsuccessfully.The valve setting did not change with the tool kit and etk and neodymium.The provider attempted to change the setting for one hour under fluoroscopy without success.On (b)(6) 2020, the patient was taken to the operating room and the valve was replaced to a new one.The patient is following up with the provider.

Manufacturer Narrative

Updated fields: d4, d10, g1, g4, g7,h2, h3, h4, h6, h10.Unique device identifier (udi) : (b)(4).The valve was returned for evaluation: failure analysis - the valve was visually inspected; a cut/torn was noted in the silicone housing in the needle chamber, and a bump mark was noted in the valve upper casing as well as the axis has come out of position.The valve has received a hard knock dislodging the rotation construct mechanism.The valve was hydrated.The valve was tested for programming the valve failed the test.The valve was stuck at setting 7 and the rotating construct was stuck in the upper position.The valve was flushed and no occlusion was noted but a leakage was noted through the cut/torn in the needle chamber.The valve was leak tested only leaked from the cut/torn in the needle chamber.The valve was dismantled and was examined under microscope at appropriate magnification.Marks were noted in the upper casing due to hard knock.The valve passed the test for reflux and siphon guard.The root cause for the bump mark noted in the valve upper casing as well as the axis has come out of position and probably the cut/torn in the silicone is due to the valve receiving a very hard knock.

Event Description

N/a.

• Brand Name: CERTAS INLIN VLV ONLY W/SPHNGD
• Type of Device: CERTAS PLUS W/ SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11042084
• MDR Text Key: 222636497
• Report Number: 3013886523-2020-00256
• 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,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 9 YR