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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES INC. OPTION ELITE FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
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.

 
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Brand NameOPTION ELITE
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
ARGON MEDICAL DEVICES INC.
1445 flat creek rd.
athens TX 75751
MDR Report Key6987146
MDR Text Key90630737
Report Number6987146
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/20/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/30/2017
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device LOT NumberQ1162263
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/20/2017
Device Age7 dy
Event Location Hospital
Date Report TO Manufacturer09/20/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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