MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MEDOS PROG INFANT VALVESYSTEM; CHPV

Catalog Number 823101

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 05/13/2021

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 a shunt valve was unable to maintain its programmable setting.A codman hakim programmable valve was implanted in a patient via ventricular peritoneal shunt 9 years prior with an initial setting of 150mmh20.The setting was changed from 200mmh2o to 150mmh2o on (b)(6) 2021.It is unknown if the patient experienced any signs or symptoms.On (b)(6) 2021, the opening pressure was confirmed by contrast enhancement, and when the pressure was confirmed again, the setting was changed to 70mmh2o.On (b)(6), 2021, the patient was taken to the operating room for a shunt revision and the valve was replaced.The patient is in follow up.

Manufacturer Narrative

The hakim valve was not returned for evaluation and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer 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.

Event Description

N/a.

Manufacturer Narrative

The valve was returned for evaluation.Device history record (dhr) - the product code 82-3101 with lot cmgcrl, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; the stator was dislodged and a 2 bump marks in the valve casing were noted.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: 2 bump marks were noted in the valve casing, and corrosion on the stator.The cam magnets were controlled and failed.The valve was leak tested and no leaks noted.The valve passed the test for occlusion.The root cause for issue reported by the customer is due to the valve receiving a hard knock.The root cause for the bump marks 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 9 years.The root cause for the abnormal polarization was probably caused by an exposition of a too strong magnetic field, as noted in the "ifu", ¿any magnet may experience a degradation of magnetic field strength as a consequence of exposure to the significantly stronger magnet field induced in a mri procedure.The root cause for the failed reflux test is due to the stator dislodged.

Event Description

N/a.

• Brand Name: MEDOS PROG INFANT VALVESYSTEM
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11956731
• MDR Text Key: 256728448
• Report Number: 3013886523-2021-00248
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 823101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1