MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. OPTION IVC FILTER; RETRIEVABLE INFERIOR VENA CAVA FILTER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Pain (1994); Thrombosis (2100); Thromboembolism (2654)

Event Date 05/05/2017

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

Subject is a (b)(6) male enrolled in (b)(6) on (b)(6) 2017 with option¿ elite retrievable vena cava filter placed on same day due to history of left lower extremity dvt and contraindication to anticoagulation due to upcoming hernia repair surgery.Subject was discharged from hospital on (b)(6) 2017.Admitted on (b)(6) 2017 with left lower extremity pain and presyncope and was found to have extensive caval and lle thrombosis with a large venous thromboembolism extending both below and above his ivc with acute pes.Thrombosis was occlusive, involving the inferior iliac vein, left common femoral vein, and left femoral vein.At this time subject was on chronic coumadin but with reported history of difficulty achieving therapeutic inrs.Subject had bilateral ekos catheters placed on (b)(6) 2017 and was discharged on (b)(6) 2017 with ongoing symptoms.The event was considered possibly related to the ivc filter or procedure.

• Brand Name: OPTION IVC FILTER
• Type of Device: RETRIEVABLE INFERIOR VENA CAVA FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 8804487
• MDR Text Key: 151500703
• Report Number: 1625425-2019-00199
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/01/2005,06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR