MAUDE Adverse Event Report: ALN S.A.R.L. ALN OPTIONAL VENA CAVA FILTER

Model Number	FJ.120096
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient underwent the ivc filter placement about 1.5 years ago (approximate implantation date: (b)(6) 2022).The attending physician this time observed under computed tomography at the patient's 1.5-year follow-up visit that the inferior vena cava was perforated.To be more specific, the physician observed the perforation by and deviation of 6 legs of the filter.Damages to the aorta were also deeply concerned.The physician removed the filter surgically.The removed filter was disposed of by the medical institution.Patient's condition after the operation: favorable.This information was obtained through a poster presentation at the japanese society for vascular surgery.

• Brand Name: ALN OPTIONAL VENA CAVA FILTER
• Common Device Name: VENA CAVA FILTER
• Manufacturer (Section D): ALN S.A.R.L.; 589 chemin du niel; bormes les mimosas, 83230 ; FR 83230
• Manufacturer (Section G): ALN S.A.R.L.; 589 chemin du niel; bormes les mimosas, 83230 ; FR 83230
• Manufacturer Contact: séverine joly ; 589 chemin du niel; bormes les mimosas, 83230 ; FR 83230
• MDR Report Key: 19738299
• Report Number: 3007080617-2024-00001
• Device Sequence Number: 7776844
• Product Code: DTK
• UDI-Device Identifier: 03760017680011
• UDI-Public: 03760017680011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2024

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 Model Number: FJ.120096
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2024
• Initial Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 93 KG