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

Lot Number Q1082113

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 09/26/2017

Event Type  Injury  

Event Description

The subject is a (b)(6) female enrolled in preserve on (b)(6) 2017 and an option¿ elite ivc filter by argon was placed for a contraindication to anticoagulation due to upcoming surgery.On (b)(6) 2017 the subject came in for the filter retrieval visit.At the time of retrieval, the filter was discovered to have a fracture of a single strut, assessed as being pre-existing, rather than a result of filter retrieval.The filter strut had migrated to the left pulmonary artery but was snared successfully.The event resolved without sequelae on the same day.

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.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Type of Device: OPTION ELITE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 13018160
• MDR Text Key: 283090587
• Report Number: 0001625425-2021-01222
• 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: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• 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 Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/29/2020
• Device Lot Number: Q1082113
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Other