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

Catalog Number	823184
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Myocardial Infarction (1969)
Type of Reportable Event	Death
Event or Problem Description
This is 1 of 2 reports linked to mfg report numbers: 3013886523-2023-00293 the patient¿s son reported a hakim valve (id 823184) and bactiseal catheter (id 823072) were implanted in his father in (b)(6) 2022.According to the son, there was no infection before the operation.He approached the surgeon due to his father¿s weight reduction and poor response at the end of (b)(6) 2022, and he was informed that by adjusting the pressure, the patient will be back to normal and pressure was adjusted two times (setting not provided).The patient was admitted in the hospital for more than 10 days only for observation and was informed that the patient will become normal in the two weeks period.In january 2023, the patient was admitted again due to poor response and after 4 days the patient had an infection.The surgeon informed them that the patient had an infection and a myocardial infarction (mi).The patient expired on (b)(6) 2023.
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.
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 could be linked to the patient and hospital surroundings.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.A medical assessment was requested to our medical safety department: conclusion: the narrative describes a procedurally related event only.There is no evidence that supports a causal relationship to the device.
Event or Problem Description
N/a.

• Brand Name: PROG VALVE RIGHT ANGLE
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; ch-2400; mansfield MA ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17691195
• Report Number: 3013886523-2023-00292
• Device Sequence Number: 6378630
• Product Code: JXG
• UDI-Device Identifier: 10381780519263
• UDI-Public: (01)10381780519263(17)260930(10)5885822
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 823184
• Device Lot Number: 5885822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/26/2023
• Date Device Manufactured: 10/14/2021
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown