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

Model Number 352506070E

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problem Pulmonary Embolism (1498)

Event Date 08/14/2018

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) 2017 by dr. (b)(6). The first option elite vena cava filter was retrieved on (b)(6) 2018. The patient was then implanted with a second option elite vena cava filter on or about (b)(6) 2018 by dr. (b)(6). The second option elite vena cava filter was retrieved on (b)(6) 2018. The patient was then implanted with a third option elite vena cava filter on or about (b)(6) 2018 by dr. (b)(6). The complaint alleges there was breakthrough pulmonary embolism, embedment, tilt, migration, multiple retrieval surgeries and ivc stenosis post-implant, but does not elaborate on what injuries occurred with each individual filter. The third filter was not retrieved. Argon¿s attorneys are attempting to gather additional information.

• 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
• Manufacturer Contact: gina liu ; 1445 flat creek rd, athens, tx 75751
• MDR Report Key: 10706475
• MDR Text Key: 212296043
• Report Number: 1625425-2020-00673
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (Y/N): N
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: OTHER

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/20/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 01/29/2021
• Device MODEL Number: 352506070E
• Device Catalogue Number: 352506070E
• Device LOT Number: Q1263318
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated By Manufacturer?: No
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient TREATMENT DATA

Date Received: 10/20/2020 Patient Sequence Number: 1