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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OPTION ELITE RETRIEVABLE VENA CAVA FILTER OPTION ELITE

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OPTION ELITE RETRIEVABLE VENA CAVA FILTER OPTION ELITE Back to Search Results
Model Number 352506070
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems High Blood Pressure/ Hypertension (1908); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Event Date 11/04/2016
Event Type  Injury  
Event Description
Subject is a (b)(6) female enrolled in preserve on (b)(6) 2016 and had an option¿ elite ivc filter by argon placed. Anticoagulation therapy is contraindicated, as subject is pre-op for neurosurgery. Medical history includes hypertension requiring medication, a current malignancy and current right lower extremity dvt limited to below the popliteal vein. On (b)(6) 2016 during the three month follow up visit, new left lower extremity swelling was observed. An ultrasound was obtained and it demonstrated a new clot in the left lower calf. The subject was on anticoagulation medication and was discharged to home. An ultrasound is planned prior to filter removal. The site reported the event was an acute episode, and considered resolved without sequelae on (b)(6) 2016. On (b)(6) 2017, the filter was successfully retrieved without complications.
 
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.
 
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Brand NameOPTION ELITE RETRIEVABLE VENA CAVA FILTER
Type of DeviceOPTION ELITE
Manufacturer Contact
elnaz rahman
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key13017700
MDR Text Key282328394
Report Number0001625425-2021-01213
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081410
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Model Number352506070
Device Lot NumberQ923539
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/03/2021
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 Treatment Data
Date Received: 12/16/2021 Patient Sequence Number: 1
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