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

Model Number 352506070E

Device Problems Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

The sample is expected to return for evaluation.A follow-up report will be submitted once the sample has been received and reviewed.

Event Description

Dr.(b)(6) was deploying a standard option elite ivc filter via jugular approach using the otw technique with an amplatz wire.The cartridge was snapped into place.While using the dilator to push the filter down the sheath into position there was noticeable resistance.The dilator was removed and flushed.Another attempt made to push the filter into position.Dr.(b)(6) felt resistance trying to advance the dilator but also felt the sheath had resistance and was backing out.She decided to remove all the components and swap out for another kit.Upon removing the components, while leaving the amplatz wire in, the filter legs got partially exposed in the svc.An unsuccessful attempt was made to re-sheath the filter as a snare could not operate properly through the sheath to snare the filter.The filter ended up deployed in the svc.A second interventional radiologist came in to retrieve the filter and place a new option elite without incident.

Manufacturer Narrative

The customer returned the delivery catheter sheath, pusher wire, dilator, and filter removed from the cartridge.A minor kink was found on one anchor of the filter which unkinked once the filter was soaked in warm water for 3-5 seconds.The product failure mode could not be duplicated so the complaint could not be confirmed.

Event Description

Detailed experience from (b)(6): (b)(6) 2021.Dr (b)(6) was deploying a standard option elite ivc filter via jugular approach using the otw technique with an amplatz wire.The cartridge was snapped into place.While using the dilator to push the filter down the sheath into position there was noticeable resistance.The dilator was removed and flushed.Another attempt made to push the filter into position.Dr (b)(6) felt resistance trying to advance the dilator but also felt the sheath had resistance and was backing out.She decided to remove all the components and swap out for another kit.Upon removing the components, while leaving the amplatz wire in, the filter legs got partially exposed in the svc.An unsuccessful attempt was made to re-sheath the filter as a snare could not operate properly through the sheath to snare the filter.The filter ended up deployed in the svc.A second interventional radiologist came in to retrieve the filter and place a new option elite without incident.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Type of Device: RETRIEVABLE IVC FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12211755
• MDR Text Key: 265142512
• Report Number: 0001625425-2021-01043
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00886333217151
• UDI-Public: 00886333217151
• Combination Product (y/n): N
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2023
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: 11343382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1