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

Model Number	82-3112
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A physician reported a hakim valve was implanted via v-p shunt in 2014 with unknown setting.Gait disturbance improved with 16 cm h2o.The patient was in good health for four years, but became ill around 2018 and began to fall repeatedly at the end of 2020.After that, the gait disorder progressed further.Since the tendency of overdrainage was confirmed by diagnostic imaging, the physician looked at the situation of 200mm h2o.The situation did not change, and endoscopic third ventriculostomy was performed on (b)(6) 2022, and the valve was removed.Immediately before the operation, the ventricular pressure was measured again, but the pressure was as low as 200 mmh2o.It is unknown if the valve was replaced.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim valve (id 823112) was returned for evaluation.Device history record (dhr) - the product code 823112 with lot 3638097 conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; no defects were noted.The position of the cam when valve was received was 180mmh2o.The valve was hydrated.The valve was leak tested and no leaks noted.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the valve mechanism, at the time of investigation functional issues were noted.

• Brand Name: PROG VALVE MICRO
• Common Device Name: 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: 13444665
• Report Number: 3013886523-2022-00032
• Device Sequence Number: 16655486
• Product Code: JXG
• UDI-Device Identifier: 10886704041474
• UDI-Public: (01)10886704041474(17)170831(10)CNJCV5
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 82-3112
• Device Catalogue Number: 823112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown