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

Model Number	FJ.HOOK
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter also sent the report mw5095860 to fda.
Event or Problem Description
Inferior vena cava filter was noted to be fractured with a piece of the right lateral filter leg embedded in the soft tissue surrounding the inferior vena cava - this was found during a procedure to remove the filter.The piece was left embedded within the patient (risk of removal outweighs benefit).

• 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
• MDR Report Key: 10464093
• Report Number: 3007080617-2020-00002
• Device Sequence Number: 19471118
• Product Code: DTK
• UDI-Device Identifier: 03760017680059
• UDI-Public: 03760017680059
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020
• Report Date (Section F): 08/04/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FJ.HOOK
• Device Lot Number: 260618
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/04/2020
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Weight: 115