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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES OPTION ELITE RETRIEVABLE VENA CAVA FILTER RETRIEVABLE IVC FILTER Back to Search Results
Model Number 352506070E
Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)
Patient Problem Pulmonary Embolism (1498)
Event Date 08/14/2018
Event Type  Injury  
Manufacturer Narrative

The device is indicated as unavailable for evaluation. Without the device or any images in-vivo to review, the complaint cannot be confirmed. If additional information is received in the future, a follow-up report will be provided.

 
Event Description

According to the notice received by way of a civil action complaint, the patient was prescribed and implanted with an option elite vena cava filter on or about (b)(6) 2017 by dr. (b)(6). The first option elite vena cava filter was retrieved on (b)(6) 2018. The patient was then implanted with a second option elite vena cava filter on or about (b)(6) 2018 by dr. (b)(6). The second option elite vena cava filter was retrieved on (b)(6) 2018. The patient was then implanted with a third option elite vena cava filter on or about (b)(6) 2018 by dr. (b)(6). The complaint alleges there was breakthrough pulmonary embolism, embedment, tilt, migration, multiple retrieval surgeries and ivc stenosis post-implant, but does not elaborate on what injuries occurred with each individual filter. The third filter was not retrieved. Argon¿s attorneys are attempting to gather additional information.

 
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Brand NameOPTION ELITE RETRIEVABLE VENA CAVA FILTER
Type of DeviceRETRIEVABLE 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 Key10706475
MDR Text Key212296043
Report Number1625425-2020-00673
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
PMA/PMN NumberK133243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 10/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/20/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/29/2021
Device MODEL Number352506070E
Device Catalogue Number352506070E
Device LOT NumberQ1263318
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 10/20/2020 Patient Sequence Number: 1
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