MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMABLE VALVE; CHPV

Catalog Number 823100

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Headache (1880); Cerebral Ventriculomeglia (2133); Vomiting (2144)

Event Date 01/08/2021

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 underdrainage from a ventricular peritoneal shunt valve.A hakim valve was implanted in a patient via ventricular peritoneal shunt more than 10 years ago with an unknown setting.On (b)(6) 2021, the patient complained of headache and vomiting.The brain mri demonstrated poor flow of the valve and ventricular enlargement were observed.Therefore, the patient was taken to the hospital and the valve was replaced to a new certas valve.The patient reportedly recovered.No further information was provided by the hospital.

Manufacturer Narrative

The hakim valve was returned for evaluation: device history record (dhr) - lot number 3513895, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected: it was noted that all the valve casing and mechanism has moved forward in the pumping chamber.The valve was hydrated.The valve was then pressure tested and failed the test due to the casing and mechanism not at the correct location.The valve passed the test for programming, occlusion, reflux and no leakage noted.The root cause for the reported ¿patient complained of headache and vomiting; poor flow and the ventricular enlargement were observed" was due to pressure regulation issues.The root cause for pressure regulation issues was due to the casing and mechanism not at the correct location.It has moved forward in the pumping chamber.The exact root cause for the casing displacement could not be determined.It was highly improbable to attribute it to patient's receiving a hard knock since no damage was found on the valve.It was highly improbable to attribute it to surgeon mishandling since various configurations were tested to try to move the casing and shown it was nearly impossible to do such.It was highly improbable to attribute it to manufacturing since some testing/controls could not have been performed by operators if the casing was already placed at incorrect location.Furthermore, the surgeon would have reported difficulties in operating room and would certainly not have implanted the device.The root cause for the casing and mechanism displacement was probably due to a combination of various unexpected events.Complaint will be closed as 'pressure regulation issues'.

Event Description

N/a.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11295649
• MDR Text Key: 234417033
• Report Number: 3013886523-2021-00069
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 823100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR