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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES INC. OPTION IVC FILTER RETRIEVABLE INFERIOR VENA CAVA FILTER Back to Search Results
Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395)
Patient Problems Chest Pain (1776); Embolism (1829); Respiratory Distress (2045)
Event Date 03/31/2016
Event Type  Injury  
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. Vena cava or other vessel injury or damage, including rupture or dissection, possibly requiring surgical repair or intervention", "filter migration/movement", "respiratory insufficiency or failure", "thromboembolic events, including dvt, acute or recurrent pulmonary embolism or air embolism, "vena cava stenosis or occlusion", and "vasospasm or decreased/impaired blood flow" are potential complications cited in the ifu associated with this product.

 
Event Description

According to the notice received by way of a civil action complaint filed on march 27, 2017 the patient was prescribed and implanted with an option retrievable ivc filter on or about (b)(6) 2011 by dr. (b)(6) at (b)(6). The patient presented to (b)(6) medical center emergency department on (b)(6) 2016 complaining of chest pain and shortness of breath. A ct scan was done which allegedly showed a ¿bilateral acute pulmonary embolism and that the filter was tilted, eroded into the lumen and migrated. Further, the patient alleges ¿the discharge summary states that the displaced ivc filter could be the source of the pulmonary embolism itself. ¿ the patient alleges significant injuries including an embedded filter, pulmonary embolism and filter migration. Argon¿s attorneys are attempting to gather information.

 
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Brand NameOPTION IVC FILTER
Type of DeviceRETRIEVABLE 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 Key6519124
MDR Text Key73611576
Report Number1625425-2017-00056
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 04/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2017
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
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/25/2017 Patient Sequence Number: 1
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