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

Model Number	823184
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve (id 823184) was implanted on (b)(6), 2022.A shunt blockage or malfunction was observed.The patient experienced enlarged ventricles due to underdrainage approximately 2 to 3 weeks after implantation.Due to product issue the valve was removed on (b)(6), 2022.
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
N/a.
Additional Manufacturer Narrative
The hakim valve (id 823184) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.However, a probable root cause for the reported complaint is due to biological debris and protein build up interfering with the valve mechanism.As no valve was returned for investigation this could not be confirmed.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.

• Brand Name: PROG VALVE RIGHT ANGLE
• 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: 16109054
• Report Number: 3013886523-2023-00002
• Device Sequence Number: 16956943
• Product Code: JXG
• UDI-Device Identifier: 10381780519263
• UDI-Public: (01)10381780519263
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2023

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: 09/30/2026
• Device Model Number: 823184
• Device Catalogue Number: 823184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 03/29/2023
• Date Device Manufactured: 10/15/2021
• 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 Age: 40 YR
• Patient Sex: Male