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

Model Number 352506070E

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

Patient Problems Dyspnea (1816); Embolism (1829); Thrombus (2101)

Event Date 09/05/2017

Event Type  Injury  

Manufacturer Narrative

The device is unavailable for evaluation.Without the sample or visual evidence to review, the root cause cannot be determined.If additional information is received in the future, a follow-up report will be provided.

Event Description

Subject is a (b)(6) year old female with current malignacy, shortness of breath, unilateral segmental pulmonay embolism, right lower extremity common femoral and external illiac dvt, and caval thrombosis 2-7 cm caudal to the lower renal vein.Contraindication to anticoagulation due to recent postoperative state.On (b)(6) 2017 subject was admitted to hospital.On (b)(6) 2017, subject was consented and option¿ elite retrievable vena cava filter was placed without complication.She was discharged on (b)(6) 2017.During prolonged hospitalization (b)(6) 2018 - (b)(6) 2017 for an unrelated condition, a ct scan on (b)(6) 2018 was noted to demonstrate "new or thrombus or substantial superior extension of limited previous thrombus, with new near complete filling of the intrahepatic cava extending from the ivc filter to the confluence of the hepatic veins." this was one of many issues noted during this prolonged hospitalization and is included as an sae due to (possible) prolongation of hospitalization related to this event.Given pre-existing tumor thrombus and the development of this finding in the context of other sites of metastatic disease showing progression, it is unknown if this represents bland thrombus propagation or tumor thrombus propagation.Based on similar descriptions of extent of ivc thrombus over numerous subsequent ct scans, it appears clinical stability related to this problem was achieved on (b)(6) 2018.At the time of this report the event was considered ongoing.The pi considered the event expected a possibly related to the ivc filter or procedure.Subject was considered lost to follow-up with her last completed visit at 6 months post-filter placement on (b)(6) 2018.

• 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: 10286794
• MDR Text Key: 199266291
• Report Number: 1625425-2020-00411
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00886333217151
• UDI-Public: 00886333217151
• Combination Product (y/n): N
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2019
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: Q1122619
• Was Device Available for Evaluation?: No
• Date Device Manufactured: 04/06/2017
• 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