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

Model Number 352506070E

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Perforation (2001)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation and no images or videos have been provided of the filter in-vivo, so the complaint cannot be confirmed.If additional information is provided in the future, this issue will be reevaluated as needed.

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) at (b)(6) health system in (b)(6).The complaint alleges there was migration and perforation.The filter was not retrieved.Argon¿s attorneys are attempting to gather additional information.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Type of Device: OPTION ELITE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 12900671
• MDR Text Key: 281504242
• Report Number: 0001625425-2021-01163
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00886333217151
• UDI-Public: 00886333217151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/30/2019
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: Q1067800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other