MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG; CHPV WITH SG

Catalog Number 823162

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 11/09/2021

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 hakim valve was implanted via v-p shunt on unknown date with unknown setting.The postoperative status was stable, however, the patient had a cerebral hemorrhage in (b)(6) 2021.In late august, the set pressure of the valve could not be changed.In september and october, the set pressure could not be changed even with neodymium.The valve was removed and replaced on (b)(6) 2021.

Manufacturer Narrative

The hakim valve (id 823162) was returned for evaluation.Device history record (dhr) - the product code 823162 with lot cnmbmd, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at 110 mmh2o.The valve was visually inspected; the silicone was cut/torn around the siphon guard.The valve was hydrated.The valve could not be leak tested due to the damage silicon housing.The valve could not be reflux tested due to the damaged silicone housing.The siphon guard was visually inspected and some marks were noted on the siphon guard.The valve passed the test for programming, occlusion and pressure.The root cause for the torn/cut silicon housing was probably due to a sharp or pointed object coming into contact with the silicone housing, as noted in the ifu silicone has a low cut/tear resistance.The root cause for the marks on the siphon guard was probably due to a sharp or point object coming into contact with the siphon guard.The possible root cause for the issue reported by the customer could have been due to biological debris and protein build up interfering with the valve mechanism, but at the time of investigation no programming issues were noted.

• Brand Name: PROG VALVE INLINE W SG
• Type of Device: CHPV WITH 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: 12869349
• MDR Text Key: 281210220
• Report Number: 3013886523-2021-00521
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K041296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 823162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2012
• 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: 62 YR
• Patient Sex: Male