MAUDE Adverse Event Report: ALN IMPLANTS CHIRURGICAUX ALN; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number FILTER KT VENA CAVA JUG 7FRX59

Device Problems Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)

Event Date 07/06/2020

Event Type  malfunction  

Event Description

During removal of an inferior vena cava filter a tiny fragment of the guidewire was sheared from the wire.The fragment remains embedded in the patient (risk of removal outweighs benefit).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).Fda safety report id # (b)(4).

• Brand Name: ALN
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): ALN IMPLANTS CHIRURGICAUX; FR
• MDR Report Key: 10361651
• MDR Text Key: 201855483
• Report Number: MW5095860
• Device Sequence Number: 2
• Product Code: DTK
• UDI-Device Identifier: 03760017680059
• UDI-Public: 03760017680059
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/31/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FILTER KT VENA CAVA JUG 7FRX59
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 115