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

Catalog Number 823164

Device Problem No Device Output (1435)

Patient Problems Headache (1880); Failure of Implant (1924)

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 the inability to change a shunt valve setting.The hakim programmable in-line valve was implanted in a patient via a ventricular peritoneal shunt on an unknown date with an unknown initial setting.It was reported that the (b)(6) patient has had shunt failure since 2017.The patient had a headache and went to an emergency department on an unknown date.Since the setting pressure could not be changed, the shunt was replaced on unknown date.The procedure was finished without any problems.The patient is in the follow up.No further information was provided by hospital.

Event Description

N/a.

Manufacturer Narrative

Updated fields:  d4, d9, g3, g6, h2, h3, h4, h6, h10.The valve was returned for evaluation.Device history record (dhr) - the product code 82-3164 with lot cpjbfk, 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 70mmh2o.The valve was hydrated.The valve was tested for programming, the valve failed the test, the cam mechanism did not move during the programming process.The silicone was cut just after valve casing the cam mechanism was gently moved.The valve was retested for programming, the valve failed the test, the cam mechanism did not move during the programming process.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found on the spring, on the spring pillar, on the cam mechanism, and on the base plate.The cam magnets were controlled per process.The magnets passed.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for occlusion, reflux and pressure.The root cause for the programing issue reported by the customer was due to biological debris and protein build up found on the spring, on the spring pillar on the cam mechanism, and on the base plate.

• Brand Name: PROG VALVE INLINE
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11713169
• MDR Text Key: 249758210
• Report Number: 3013886523-2021-00184
• 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
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 823164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR