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

Catalog Number 352506070E

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation (2001)

Event Date 12/23/2014

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.Incorrect positioning or orientation of the filter is one of the potential complications cited in the ifu associated with this product.In the ifu, step 28 of the recommended filter implantation states ¿perform a control cavagram prior to terminating the procedure.Verify proper filter positioning¿.¿device breakage or failure or inability to retrieve implanted device as described in ifu, possibly requiring another intervention or treatment modality to complete procedure¿, "vena cava or other vessel injury or damage, including rupture or dissection, possibly requiring surgical repair or intervention" and "injury or damage to organs adjacent to vena cava, possibly requiring surgical repair or intervention" 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 (b)(6) 2017, the patient was prescribed and implanted with an option elite retrievable ivc filter on or about (b)(6) 2014 by dr.(b)(6) at (b)(6).The patient had a scheduled retrieval approximately 3 months later, on or about (b)(6) 2014 by dr.(b)(6) at (b)(6).The physician was unable to retrieve the filter due to embedment, tilt, migration and perforation.Argon¿s attorneys are attempting to gather additional information.

• Brand Name: OPTION IVC FILTER
• Type of Device: RETRIEVABLE 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 Key: 7152811
• MDR Text Key: 96005428
• Report Number: 1625425-2017-00172
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 352506070E
• Device Lot Number: Q558064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other