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

Model Number	FJ.120096
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Event: vascular injury.On (b)(6) 2021, the patient underwent an aln filter implantation in the infrarenal inferior vena cava to prevent pulmonary thromboembolism.On (b)(6) 2021, the patient complained of back pain.Ct was performed and showed that the lumbar artery near the implanted filter was damaged and bleeding.It became a large hematoma compressing the vena cava.The patient underwent an acute procedure.A cuff of afx stent graft system ((b)(6) lifeline) was placed in the aorta to stop the bleeding.The procedure was fished.Patient's condition after the operation: the patient is no more in pain.The hematoma however still compresses the filter and the vena cava, which became narrowed and deformed.Physician's comment: i implanted the filter successfully and appropriately in order not to compress the vessels, although the target vein might have been smaller in diameter than i thought.Images taken after the implantation suggested no problem.I suspected the implanted filter caused the pain based on the area the patient indicated, so i took a ct scan right away.The patient might have died if i had not found the bleeding then.
Event or Problem Description
The patient is observed in the hospital, and in stable condition without any complications of retroperitoneal hematoma.

• 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: 11451141
• Report Number: 3007080617-2021-00001
• Device Sequence Number: 4048999
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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
• Operator of Device: Health Professional
• Device Model Number: FJ.120096
• Device Lot Number: 050418
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 10/24/2021
• 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: Life Threatening