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

Model Number	FF.HOOK
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the retrieval procedure of the vena cava filter, a small fragment of one of the filter's legs fractured and remained inside the patient's body.The patient is currently asymptomatic.
Additional Manufacturer Narrative
We require additional information to understand how the legs could have fractured at that specific location, particularly regarding the retrieval procedure, whether it was performed using an aln removal kit or a snare.We also need the full cavography sequence in order to assess the entire extraction process, together with pre-operative and post-operative scans to complete our investigation.
Event or Problem Description
The filter was placed on the (b)(6) 2024 and removed on (b)(6) 2025.Lasso technique was used for the filter removal (cook cloversnare®).

• 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: 22529990
• Report Number: 3007080617-2025-00001
• Device Sequence Number: 7488289
• Product Code: DTK
• UDI-Device Identifier: 03760017680042
• UDI-Public: 03760017680042
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K241507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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: FF.HOOK
• Device Lot Number: 2400177234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• 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: Other
• Patient Sex: Unknown