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

Catalog Number 823100

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 01/24/2022

Event Type  Injury  

Event Description

A physician reported a hakim valve (id 823100) was implanted via ventricular peritoneal shunt in (b)(6) 2021 with unknown setting.An obstruction was suspected because the flow was slow and on (b)(6) 2022 the valve was removed and replaced.It is unknown if the patient experienced any signs and symptoms.Patient is in follow up.

Manufacturer Narrative

The hakim valve (id 823100) was not returned for evaluation (as per customer, product not available) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.The possible root cause for issue reported by the customer could be due to biological debris and protein build up interfering with the valve mechanism.

Manufacturer Narrative

The hakim valve (id: 823100) was returned for evaluation: device history record review - the lot history record was reviewed for completeness during the release process to inventory.At that time based on the fact that no discrepancies were noted for the products being accepted, they were released to stock on the 11th november 200449 parts released to stock.Failure analysis: the valve was visually inspected; cut/tear/holes on the silicon housing on the sides of the valve casing were noted, the stator and the x-ray dot were dislodged.The valve could not be program tested due to the dislodged stator.The valve was reflux tested and failed.The valve could not be pressure tested, due to the dislodged stator.The valve was dismantled and was examined under microscope at appropriate magnification: marks on the valve casing, corrosion on the x-ray dot and corrosion on the stator were noted.The valve was leak tested and no leaks noted.The valve passed the test for occlusion.The cam magnets were controlled and passed successfully.Root cause - the possible root cause for occlusion issue reported by the customer was probably due to biological debris and protein build up interfering with the valve mechanism.At the time of the valve investigations, no occlusion issue was noted.The root cause for the marks in the valve casing are due to the valve receiving a sharp or pointed object.The root cause for the failed reflux test is due to the dislodged stator.The root cause for the stator and x-ray dot dislodging is due to 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.This valve was implanted for at least 10 years.According to the serial number of the returned valve, it is not possible that the valve was implanted on (b)(6) 2021.The returned valve was produced in 2004 per the serial number noted on the device.

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
• 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: 13485900
• MDR Text Key: 285333452
• Report Number: 3013886523-2022-00039
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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