MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. OPTION ELITE; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Lot Number Q1162263

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395)

Patient Problems Pulmonary Embolism (1498); Chest Pain (1776); Death (1802); Hemorrhage/Bleeding (1888); Dizziness (2194); Loss of consciousness (2418)

Event Date 08/21/2017

Event Type  malfunction  

Event Description

Fourteen months ago, the patient underwent surgical resection of lumbar schwannoma and post-operative course was complicated by a dural leak.This required a prolonged period of bed rest during which the patient developed pulmonary emboli.An inferior vena cava filter was placed about 2 months ago.Six days later, the patient complained of being lightheaded and developed right-sided chest pain.That evening, the patient became hemodynamically unstable and coded in the icu.A ct scan showed migration of the vena cava filter to the heart.The patient was taken to the or for extraction of the filter.Unfortunately, the patient did not regain consciousness following code/emergent surgery and passed away 3 days later.

• Brand Name: OPTION ELITE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek rd.; athens TX 75751
• MDR Report Key: 6987146
• MDR Text Key: 90630737
• Report Number: 6987146
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: Q1162263
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2017
• Device Age: 7 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 155