MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. OPTION ELITE RETRIEVABLE VENA CAVA FILTER

Catalog Number 352506070E

Device Problem Peeled/Delaminated (1454)

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

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

There was no patient injury.Because the legs were bent upward, the filter had to be removed.After removal of the filter, the legs straightened back out.The manufacturing dhr was reviewed and no non-conformances were noted.Proper materials and methods of manufacturing were utilized.The filter, pusher wire, delivery sheath, dilator, and a long strip of the ptfe interior lining of the sheath were returned.The sheath id was in specification and no concerns were observed with regard to the filter.However, it was noted that delamination occurred along the length of the sheath, beginning at the hub.Although a definitive root cause of the reported issue could not be determined, a potential cause could be that the pusher wire was not placed into the center of the lumen of the filter, which would prevent the filter from centering in the sheath.This may have allowed the filter hooks to engage the sheath wall, causing the delamination.The filter leg bending upward may have been caused by the leg being tangled in the pieces of the sheath lining, or the filter legs engaging the sheath tip (as a result of having engaged the sheath wall).

Event Description

Physician successfully inserted filter, upon removing the sheath it appears as if the leg of the filter may have peeled off some of the inner sheath and it was still attached to one of the filter legs.This caused the leg to bend upward.Filter removed successfully and the leg straightened back out.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Type of Device: OPTION ELITE RETRIEVABLE
• 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: 5511528
• MDR Text Key: 40775966
• Report Number: 1625425-2015-00095
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143405
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/30/2018
• Device Catalogue Number: 352506070E
• Device Lot Number: Q886288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention