MAUDE Adverse Event Report: ALN IMPLANTS CHIRURGICAUX 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)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the patient underwent an ivc filter implantation procedure.The implanted filter tilted and not perforated the vessel wall.On an unknown date of (b)(6) 2022, the patient underwent ct scan for filter extraction procedure, which showed two of the anchorage struts perforated the vessel wall.On (b)(6) 2022, the patient underwent a filter extraction procedure.The filter was extracted.Postoperative angiography did not show contrast agent leaked from the blood vessels.Patient's condition favorable after the operation.

• 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: 14286470
• Report Number: 3007080617-2022-00002
• Device Sequence Number: 11177512
• 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
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2022

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
• Device Lot Number: 080219
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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