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

Catalog Number 823184

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Failure of Implant (1924)

Event Date 04/01/2021

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 codman hakim, programmable valve was implanted in a patient on (b)(6) 2021 with spontaneous hydrocephalus.The patient was initially admitted to the hospital on (b)(6) 2021 and taken to the operating room for shunt placement on (b)(6) 2021.The shunt was over draining despite being set to the maximum pressure of 200 mm h2o.The craniectomy site was deeply sunken in.The patient clinically worsened significantly and did not improve despite multiple adjustments in the shunt.The physician reported they ¿had to block off the shunt to revive the patient¿.The patient had prolonged state of altered sensorium after the shunt surgery and needed a longer hospital stay due to the shunt malfunction.The patient was discharged home on (b)(6) 2021.The patient had returned to her pre-operative clinical status at the time of the complaint filing.The physician reported they plan to schedule surgery for a shunt revision to remove the shunt and replace with a programmable shunt.

Event Description

N/a.

Manufacturer Narrative

The hakim valve was not returned for evaluation therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.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.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up this could interfere with the valve mechanism.A medical assessment report was requested with the following conclusion: "based on the complaint information received to date, device malfunction causal to the event remains inconclusive without internal investigation of the returned device.".

• Brand Name: PROG VALVE RIGHT ANGLE
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11984272
• MDR Text Key: 255747761
• Report Number: 3013886523-2021-00269
• 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: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 823184
• Device Lot Number: 3721299
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1