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

Model Number	FF.HOOK
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Upon deployment of ivc filter, migrated to the level of the pulmonary artery.The physician was able to snare and remove the filter in its entirety.

• 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 Contact: séverine joly ; 589 chemin du niel; bormes les mimosas, 83230 ; FR 83230
• MDR Report Key: 16434056
• Report Number: 3007080617-2023-00001
• Device Sequence Number: 7449828
• Product Code: DTK
• UDI-Device Identifier: 03760017680042
• UDI-Public: 03760017680042
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K163699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/23/2023

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: 06/01/2026
• Device Model Number: FF.HOOK
• Device Lot Number: 020721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown