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

Model Number	82-3832
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Headache (1880)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a hakim valve (id 823832) was implanted via ventriculo-peritoneal (vp) shunt in 2016 with unknown setting.The patient visited the outpatient clinic on march 23, 2023 with headache.Then she visited again on (b)(6) 2023.An imaging diagnosis confirmed further extreme ventriculomegaly and with headache.The entire shunt system was checked, 3dct showed that the catheter at the proximal end of the valve was almost torn and slightly connected.On (b)(6) 2023, only the torn portion of the proximal catheter was removed, and the proximal catheter was reconnected to the valve, ligated again, and the operation was completed.The valve remains implanted.
Additional Manufacturer Narrative
Hakim valve (id 823832) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.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: 16765718
• Report Number: 3013886523-2023-00117
• Device Sequence Number: 3061590
• 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 Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2023

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 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: 03/30/2023
• Initial Report FDA Received Date: 04/18/2023
• 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: 49 YR
• Patient Sex: Female