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

Model Number	82-3164
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/09/2022
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
1 of 2 reports linked to mfg report number: 3013886523-2022-00359.A physician reported a hakim programmable valve was implanted in a 15 year-old male patient to treat aqueductal stenosis with hydrocephalus but later developed bilateral subdural collections.The subdural collections were evacuated, shunt was revised and changed to a programmable vp shunt with pressure at 70mmh2o on (b)(6) 2022.Then patient developed recurrence of bilateral subdural collection.The patient was transferred to another facility where he underwent on a re- evacuation of subdural hematoma on (b)(6) 2022 and pressure setting was increased to 110mm.He underwent a repeat ct imaging that showed no significant increment in ventricle size and hence pressure setting were against changed to 140 and later to 200.He also underwent repeat evacuation of bilateral subdural hematoma on (b)(6) 2022 because of shunt over drainage.Repeat imaging are suggestive that the pressure changes in the shunt are not working and hence shunt was ligated on (b)(6) 2022 the valve was removed.
Additional Manufacturer Narrative
The hakim valve (id 823164) was returned for evaluation.Device history record (dhr) : the product code 82-3164 with lot 212888, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; no defects noted.The position of the cam when valve was received was 50mmh2o.The valve was hydrated.The catheters were irrigated no occlusions noted.The valve was leak tested and no leaks noted.The valve passed the test for programming, occlusion, reflux and pressure.No root cause could be determined as the technician could not confirm any problems 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 no functional issues were noted with the valve.No corrective action is required given that no manufacturing, workmanship, material deficiency or adverse trend was identified.

• Brand Name: PROG VALVE INLINE
• 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: 15148288
• Report Number: 3013886523-2022-00358
• Device Sequence Number: 12159920
• Product Code: JXG
• UDI-Device Identifier: 10886704041566
• UDI-Public: (01)10886704041566(17)230731(10)212888
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

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: 07/31/2023
• Device Model Number: 82-3164
• Device Catalogue Number: 823164
• Device Lot Number: 212888
• 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: 07/15/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2018
• 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