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

Catalog Number 352506070E

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

The device is currently under evaluation.A follow-up report will be submitted when the evaluation is complete.

Event Description

Access gained using the 5fr sheath and dilator.Cavagram taken.Dilator was removed.Sheath was noted to be too high in cava.Sheath was advanced further.Filter was attached for jugular approach.Some challenge was noted during unsheathing of filter.Upon deployment it was noted that filter legs did not expand.It was noted that filter legs may be sitting within most proximal extent of clot burden.Decision was made to remove filter.Snare and 6fr terumo destination guiding sheath were used to remove filter.Cook celect was prepped and deployed without issue.This was users second use of option elite (2nd in same day).

Manufacturer Narrative

A review of the manufacturing documentation was conducted, and no similar concerns were found.Only the filter was returned for evaluation; there were no other components from the kit returned.The filter was visually inspected, and there was no damage noted on the filter.Also, the filter expanded as intended.During the investigation, the complaint mode could not be duplicated and the complaint was not confirmed.

• 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
• MDR Report Key: 8067810
• MDR Text Key: 127872171
• Report Number: 1625425-2018-00185
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): Y
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2021
• Device Catalogue Number: 352506070E
• Device Lot Number: Q1359495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/13/2018
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention