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)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, the patient underwent an ivc filter implantation procedure.The patient anatomy was tortuous.The two longest struts perforated the vessel a little bit, but were not considered serious.On (b)(6) 2022, the catheterist/physician reviewed the images and noted that two struts had vessel perforated approximately 2 cm.There was a small amount of hemorrhage from the right vessel wall where one of the struts perforated.Additional procedure have not been taken.Patient's condition after the operation: as of today: no abdominal pain, no decrease in vitals, no serious adverse event.The device will be implanted permanently.

• 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 (Section G): ALN IMPLANTS CHIRURGICAUX; 589 chemin du niel; bormes les mimosas, 83230 ; FR 83230
• Manufacturer Contact: yukari okamura ; 3-8-8, edobori, nishi-ku; osaka, ; JA
• MDR Report Key: 14572571
• Report Number: 3007080617-2022-00003
• Device Sequence Number: 5041377
• Product Code: DTK
• UDI-Device Identifier: 03760017680011
• UDI-Public: 03760017680011
• Combination Product (Y/N): N
• PMA/510(K) Number: K163699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 06/02/2022

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 Expiration Date: 01/20/2024
• 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: 05/31/2022
• Initial Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2019
• 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