MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION ELITE 100CM RETRIEVABLE VENA CAVA FILTER

Model Number 352506100E

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem Pulmonary Embolism (1498)

Event Date 03/17/2016

Event Type  Injury  

Manufacturer Narrative

The device is indicated as unavailable for evaluation.Without the device or any images in-vivo to review, the complaint cannot be confirmed.If additional information is received in the future, a follow-up report will be provided.

Event Description

According to the notice received by way of a civil action complaint, the patient was prescribed and implanted with an option elite vena cava filter on or about (b)(6) 2016 by dr.(b)(6) at (b)(6) hospital in (b)(6).The complaint alleges there was breakthrough pe, embedment, tilt and migration post-implant.The filter was unable to be removed from the inferior vena cava.Argon¿s attorneys are attempting to gather additional information.

• Brand Name: OPTION ELITE 100CM RETRIEVABLE VENA CAVA FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• Manufacturer Contact: gina liu ; 1445 flat creek rd, athens, tx 75751
• MDR Report Key: 10611440
• MDR Text Key: 209340543
• Report Number: 1625425-2020-00546
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00886333222346
• UDI-Public: 00886333222346
• Combination Product (y/n): N
• PMA/PMN Number: K143405
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 352506100E
• Device Catalogue Number: 352506100E
• Device Lot Number: Q765679
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other