MAUDE Adverse Event Report: ALN IMPLANTS CHIRURGICAUX ALN OPTIONAL VENA CAVA FILTER

Model Number	FJ.120096
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent an ivc filter implantation procedure for central deep vein thrombosis as a preventive treatment of oophorectomy.On the morning of (b)(6) 2021, the patient underwent an oophorectomy procedure.A postoperative x-ray showed the filter migrated to the superior vena cava.On the afternoon of (b)(6) 2021, the patient underwent a filter extraction procedure.The filter was retrieved successfully.No adverse effect to the patient.

• Brand Name: ALN OPTIONAL VENA CAVA FILTER
• Common Device Name: VENA CAVA FILTER
• Manufacturer (Section D): ALN IMPLANTS CHIRURGICAUX; 589 chemin du niel; bormes les mimosas, 83230 ; FR 83230
• Manufacturer Contact: severine joly ; 589 chemin du niel; bormes les mimosas, 83230 ; FR 83230
• MDR Report Key: 13590066
• Report Number: 3007080617-2021-00003
• Device Sequence Number: 14395169
• Product Code: DTK
• UDI-Device Identifier: 03760017680011
• UDI-Public: 3760017680011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2021

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
• Device Expiration Date: 01/27/2023
• Device Model Number: FJ.120096
• Device Lot Number: 150218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown