MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG; CHPV WITH SG

Model Number	82-3832
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Dementia (4405)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a hakim valve (id 823832) was implanted in a male patient via v-p shunt on (b)(6) 2014 with unknown setting due to cerebral aqueduct stenosis.The patient visited the hospital on (b)(6) 2021 and it was noted his dementia worsened.Due to suspicion of underdrainage a shunt contrast was performed, however, the flow could not be confirmed.The valve was removed and replaced on (b)(6) 2022.A water flow test was performed to the removed valve and the distal side of the valve was obstructed.
Additional Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The hakim valve was not returned for evaluation (discarded by customer) and lot number information has not 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; however, the possible root cause for the for the issue reported by the customer could be due to biological debris and protein build up interfering with the valve mechanism.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 INLINE W SG
• Common Device Name: CHPV WITH SG
• 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: 14438306
• Report Number: 3013886523-2022-00201
• Device Sequence Number: 20228809
• Product Code: JXG
• UDI-Device Identifier: 10886704041825
• UDI-Public: 10886704041825
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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 Model Number: 82-3832
• Device Catalogue Number: 823832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 77 YR
• Patient Sex: Male