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

Model Number	82-3164
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hematoma (1884)
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
2 of 2 reports linked to mfg report number: 3013886523-2022-00358.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 and on (b)(6) 2022 the valve was removed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim valve 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.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
• 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: 15148287
• Report Number: 3013886523-2022-00359
• Device Sequence Number: 5589251
• 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 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): 12/05/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 12/05/2022
• 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 Age: 15 YR
• Patient Sex: Male