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

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/29/2019

Event Type  malfunction  

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) year old female enrolled in preserve on (b)(6) 2017 with option¿ elite retrievable vena cava filter placed on same day due to history of right lower extremity dvt and contraindication to anticoagulation due to upcoming embolization of basilar apex aneurysm surgery.Subject was discharged from hospital on (b)(6) 2017.During filter retrieval on (b)(6) 2019 site reported that after snaring the hook of the filter, it was noted the single left sided filter leg remained stationary while the rest of the filter removed freely on the snare, making it clear that this single leg was fractured from the rest of the filter.After successful removal of the filter, the embedded leg was then successfully retrieved using the snare with no further fracturing.The event was considered definitely 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: 8790844
• MDR Text Key: 151747736
• Report Number: 1625425-2019-00193
• 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 Health Care Professional
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR