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

Model Number	FF.010995
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, in the interventional radiology department, the placement of an optional vena cava filter by femoral approach in a patient with bilateral pulmonary embolism with deep vein thrombosis of the lower limbs failed.Indeed, several attempts to release the vena cava within the subrenal vena cava were made, resulting in a recoil of the material caudally towards the iliac bifurcation.The critical step was the fixed point-removal using the supplied pusher which failed to release the filter.The unexpanded filter was finally released thanks to the dilator.A radiograph confirmed the poor deployment of the material and its migration in the suprarenal situation.The medical team therefore attempted to recover the material via the superior route (via the jugular approach), but this failed because the angulation of the inferior vena cava above the kidneys did not allow the device to be removed.On (b)(6) 2022, a new attempt to remove the filter was made, the latter being localized retro-hepatically.In view of the two successive failures to remove this filter, it was decided to leave it in place for life.This is an isolated incident.The consequences for the patient are mainly the need for a revocation for a new withdrawal attempt, and a delay in his other treatments.There is also a significant risk of thrombosis in the filter.

• 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: 14732761
• Report Number: 3007080617-2022-00004
• Device Sequence Number: 11331808
• Product Code: DTK
• UDI-Device Identifier: 03760017680004
• UDI-Public: 03760017680004
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2022

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: 04/22/2026
• Device Model Number: FF.010995
• Device Lot Number: 010521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2021
• 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: Hospitalization
• Patient Sex: Unknown