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

Lot Number Q1122619

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

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Vomiting (2144); Abdominal Distention (2601)

Event Date 01/13/2018

Event Type  Injury  

Event Description

Subject is a (b)(6) female with a current malignancy, breathing difficulties due to a current unilateral segmental pe, current rle in the common femoral and external iliac veins and a caval thrombosis 2-7cm caudal to the lower renal vein.She was enrolled into preserve on (b)(6) 2017 for contraindication to anticoagulation since her anticoagulation could not be initiated due to her recent postoperative state.An option¿ elite retrievable vena cava filter was placed without complication on (b)(6) 2017 and she was discharged from hospital on (b)(6) 2017.During prolonged hospitalization from (b)(6) 2018 until (b)(6) 2018, an abdominal ct on (b)(6) 2018, performed to assess new abdominal , distention, emesis, and downtrending hemoglobin, incidentally identified ¿extensive new pulmonary emboli, partially visualized, including the right lobar pulmonary arteries.¿ these new pe were identified in the context of 1) ¿new 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,¿ and 2) prior to ivc filter placement the patient was noted to have tumor thrombus in the inferior vena cava +/- additional bland thrombus, and 3) progressive metastatic disease at other sites (liver, lungs, abdomen).Thus it is unknown if new pulmonary emboli represent tumor emboli or bland thrombus emboli.The date of discharge ((b)(6) 2018) was selected as the date of resolution, after the pi's review of available medical records.

Manufacturer Narrative

Sample is unavailable for evaluation.Without such evident to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.

• 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
• MDR Report Key: 13018015
• MDR Text Key: 282967995
• Report Number: 0001625425-2021-01220
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 11/29/2019
• Device Lot Number: Q1122619
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/16/2021
• 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