MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MICRO CHPV W RICKHAM UNITIZED

Catalog Number 823113

Device Problem Device Difficult to Program or Calibrate (1496)

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 facility reported a hakim valve was implanted years ago.The patient underwent mri and the valve had to be reprogrammed.The valve was blocked at 120mmhg and the patient started to have headache, and it was removed and repalaced.

Manufacturer Narrative

The hakim valve was returned for evaluation: failure analysis - the valve was visually inspected; the proximal connector (rickham) was cut/broken away and not returned, the spring was sitting under the cam mechanism and a crack and bump mark was noted in the valve casing.The valve could not be program tested due to the spring under the cam mechanism.A metal connector was attached to the valve.The valve passed the tests for occlusion, leak and magnets.The valve could not be pressure tested, due to the cam sitting on the spring.The valve was dismantled and was examined under microscope at appropriate magnification: a crack and a bump mark were noted in the valve casing, when dismantled the stator came away from the base plate, corrosion was noted on the stator.The root cause for ¿valve could not be programmed¿ as reported by the customer is due to the valve receiving a hard knock.The root cause for the missing rickham connector is probably due to user¿s error.The root cause for the crack and bump mark in the valve casing is due to the valve receiving a hard knock.The root cause for the stator dislodging is due to the valve receiving a hard knock and the corrosion.The root cause of the corrosion, could not be clearly determined galvanic corrosion could not be established as a direct root cause for those valves investigated, however it was found to be a contributing factor when trauma to the valve was found.Corrosion, when it arises, only arises after long term exposure to csf.The valve has been implanted for at least 7 years.

Event Description

N/a.

• Brand Name: MICRO CHPV W RICKHAM UNITIZED
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• MDR Report Key: 12170747
• MDR Text Key: 261678364
• Report Number: 3013886523-2021-00306
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K053107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 823113
• Device Lot Number: CNBCF2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1