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

Catalog Number 828814

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 06/18/2021

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 a certas plus valve was implanted in a patient via ventricular peritoneal shunt on an unknown date with an initial unknown setting.The patient was taken for a shunt revision surgery on an unknown date and the valve was replaced.The physician reported a blood clot in the valve, which seemed to have blocked the valve.The patient is in follow up.No further information was provided by hospital.

Manufacturer Narrative

The certas valve was returned for evaluation.Device history record (dhr) - the product code 828814 with lot 5038061 conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 2.The valve was visually inspected; biological debris was noted inside the valve casing.The valve was hydrated.The valve was tested for programming and settings passed the rc position was not visible.The valve was flushed and failed an occlusion was noted.The valve could not be leak tested, reflux tested, or pressure tested due to the occlusion.The siphon guard was removed and passed the test.The valve was dismantled and was examined under microscope at appropriate magnification, biological debris was found on and around the ruby ball and covering the cam mechanism.The root cause for the shunt dysfunction issue reported by the customer is due to biological debris and protein buildup found on and around the ruby ball and covering the cam mechanism.

• Brand Name: CRTS SM IL 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: 12125286
• MDR Text Key: 260239501
• Report Number: 3013886523-2021-00291
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828814
• Device Lot Number: 5038061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1