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

Catalog Number 823162

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

Patient Problem Cerebral Edema (4403)

Event Date 05/19/2021

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that a hakim valve was implanted in a patient due to subdural edema via ventriculo-peritoneal shunt on (b)(6) 2021 with 60mmh2o.After implantation, the subdural edema did not improve, and even if the set pressure was reduced to 30mmh2o, it did not improve.The valve was removed and replaced on (b)(6) 2021.Subsequently, the patient's condition was good/improved.

Manufacturer Narrative

The valve was returned for evaluation: device history record (dhr) - lot 4175406 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 40mmh2o.The valve was hydrated.The valve passed the test for programming, occlusion, reflux, siphon guard, and pressure.The valve only leaked from the needle holes in the needle chamber.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, at the time of investigation no functional issues were noted.Additional information received: patient's primary disease is communicating hydrocephalus.The reason for removal was suspected shunt dysfunction.

• 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
• MDR Report Key: 12005556
• MDR Text Key: 267668445
• Report Number: 3013886523-2021-00271
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823162
• Device Lot Number: 4175406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 MO