MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION ELITE RETRIEVABLE VENA CAVA FILTER; RETRIEVABLE IVC FILTER

Model Number 352506070E

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/11/2020

Event Type  Injury  

Manufacturer Narrative

The device used is indicated as available for evaluation.As of the date of this report, it has not been returned.A follow-up report will be provided once the device has been received and reviewed.

Event Description

Dr.(b)(6) (physician) was using an option elite ivc filter to deploy the filter from a femoral approach.He had the option sheath in over a wire and was using the dilator to do a cavagram injection.Upon pulling the dilator and wire out of the sheath one of the radiopaque bands on the dilator to do a cavagram injection.Upon pulling the dilator and wire out of the sheath one of the radiopaque bands on the dilator detached and was left in the patient.The wire was also damaged upon observation upon removal from the sheath.An unsuccessful attempt was made to retrieve the band and it ended up breaking into pieces and remains lodged in an internal iliac vein.

Event Description

Follow up.

Manufacturer Narrative

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• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Type of Device: RETRIEVABLE IVC FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10442973
• MDR Text Key: 204064118
• Report Number: 1625425-2020-00482
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00886333217151
• UDI-Public: 00886333217151
• Combination Product (y/n): N
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2022
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: Q1462229
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1