MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLINE VLV ONLY; CERTAS PLUS

Catalog Number 828800

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

Patient Problem Angioedema (4536)

Event Date 02/24/2022

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 valve was implanted in a (b)(6) male patient due to inph (idiopathic normal pressure hydrocephalus) via l-p shunt on (b)(6), 2022 with unknown setting.Several days after the procedure, subcutaneous retention occurred in the shunt implanted area.The valve was removed and replaced on (b)(6), 2022.

Manufacturer Narrative

The certas valve (id (b)(4)) was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 4.The valve was visually inspected; no defects were noted.The valve was hydrated.The valve was leak tested and no leaks noted.The valve passed the test for programming, occlusion, reflux and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the valve mechanism, but at the time of investigation no functional issues were noted with the valve.

• Brand Name: CERTAS INLINE VLV ONLY
• Type of Device: CERTAS PLUS
• 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: 13863453
• MDR Text Key: 289856578
• Report Number: 3013886523-2022-00105
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 83 YR
• Patient Sex: Male