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

Catalog Number 828805

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 11/22/2021

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 on (b)(6) 2021.The patient needed a new surgery because he had signs of hydrocephalus and intracranial hypertension and it was found that the valve was "clogged".The valve was explanted on (b)(6) 2021.

Manufacturer Narrative

The certas valve (id 828805) was returned for evaluation.Device history record (dhr) - the product code 82-8805 with lot 4776332, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; needle holes in the needle chamber were noted.The position of the cam when valve was received was setting 8.The valve was hydrated.The valve was tested for programming; the valve failed the test, the rotating construct did not move during the programming process.The valve was flushed and was occluded at the ruby ball.The valve could not be reflux tested due to the occlusion.The valve could not be pressure tested due to the occlusion.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found on the rotating construct, on the helical spring and on the ruby ball.The root cause for the occlusion issue reported by the customer was due to biological debris and protein build up found on the ruby ball.The root cause for the programming issue noted during the investigation was due to biological debris and protein build up found on the rotating construct.

Event Description

N/a.

• 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: 12964816
• MDR Text Key: 286007525
• Report Number: 3013886523-2021-00548
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10886704071372
• UDI-Public: (01)10886704071372(17)250630(10)4776332
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• 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: 4776332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2020
• 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