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

Catalog Number 823101

Device Problem Communication or Transmission Problem (2896)

Patient Problem Injury (2348)

Event Date 11/24/2020

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 the hakim programmable valve was implanted to a (b)(6) y/o female patient via v-p shunt with an unknown setting for the treatment of a brain tumor.A week after placing the valve it was difficult to change the setting.Patient's hydrocephalus symptoms did not improve thus obstruction was suspected.On (b)(6) 2020, a revision surgery was done and valve was replaced with a new one.After removing the valve, the flow patency was verified and obstruction was not confirmed.The patient's protein concentration was high.

Event Description

N/a.

Manufacturer Narrative

Unique device identification (udi): (b)(4).The valve was returned for evaluation: failure analysis - the valve was visually inspected; biological debris noted inside the valve distal end as well as needle holes in the silicone housing.The position of the cam when valve was received was 50mmh2o.The valve passed the test for programming, flushed and reflux.The valve failed the test for pressure.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was noted on the spring, on the spring pillar, on the ruby ball, on the seat of the ruby ball, and on the base plate.The root cause for the pressure issue noted during the investigation is due to biological debris found on the ruby ball, on the seat of the ruby ball and the base plate, the biological debris was stopping the ruby ball from sitting correctly on the seat of the ruby ball.The possible root cause for the issues reported by the customer was probably due to biological debris and protein buildup interfering with the valve mechanism.

• 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: 10987757
• MDR Text Key: 220888820
• Report Number: 3013886523-2020-00241
• 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,u
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 823101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 94 YR