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

Model Number 352506070E

Device Problems Break (1069); Activation Problem (4042)

Patient Problem Failure of Implant (1924)

Event Date 08/05/2022

Event Type  malfunction  

Event Description

The filter damaged the end of the sheath upon deployment causing the filter to be tilted significantly.

Manufacturer Narrative

The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.

Event Description

The filter damaged the end of the sheath upon deployment causing the filter to be tilted significantly.

Manufacturer Narrative

A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.A review of the image provided by customer was performed.First and second images found coil was unwind, third image found filter was tilted.Vp, global medical affairs reviewed the image and his evaluation were as follows: "based on the imaging it looks like the coil used to reinforce the sheath somehow was liberated and started to unwind.Without being able to extract the causative mechanism as i do not have the sheath in front of me so any estimation or guess will be purely hyperbole on my part.It definitely looks like the legs or anchors on the legs were grabbed by the coil wire which could account for the wire separating out the tip of the sheath and absolutely could tilt the filter.The real question that would need to be answered by evaluating the inside of the tip of the sheath itself is why the coil was accessible to be snagged by the legs and pulled out of the sheath to begin with." after third notification, the sample was not returned for evaluation, visual evidence of any kind was not provided which would have allowed for the allegation to be reviewed.Without such evidence this complaint could not be confirmed.Since this complaint could not be further investigated, establishing a definite root cause and corrective action is not possible.If the sample is returned at a future date, this complaint will be reopened for further investigation at that time.

• 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: 15248797
• MDR Text Key: 305176056
• Report Number: 0001625425-2022-01064
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00886333217151
• UDI-Public: 00886333217151
• 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: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: 11430558
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 08/05/2022
• Supplement Dates FDA Received: 10/31/2022
• 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