MAUDE Adverse Event Report: ABBOTT VASCULAR OMNILINK ELITE PERIPHERAL STENT SYSTEM; PERIPHERAL STENT DELIVERY SYSTEM

Catalog Number UNK OMNILINK ELITE

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976); Migration (4003)

Patient Problem Vascular Dissection (3160)

Event Date 11/01/2022

Event Type  Injury  

Manufacturer Narrative

The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Estimated date of event.The udi number is not known as the part and lot number were not provided.Date of implant has been estimated.Literature attachment: article title "retrieval of a dislodged stent during transcatheter aortic valve replacement.".

Event Description

It was reported through a research article that a 74-year-old man with severe peripheral artery disease (pad) who had undergone aorto-iliac percutaneous angioplasty using the kissing-stents technique with a 9.0x59mm omnilink elite stent delivery system (sds) two years earlier was admitted for transcatheter aortic valve replacement (tavr).The right iliac intra-stent angioplasty was performed with a 7.0x40 mm armada 35 balloon dilatation catheter through an 8-french (fr) introducer immediately prior to the tavr procedure without issues.An 18-fr introducer was used, and placed with its distal end at the middle of the previously dilated stent, preventing the sheath from overcoming the proximal margin of the stent in the aorta.This provided a way for the advancement of the transcatheter aortic heart valve.During deployment of the transcatheter aortic heart valve, an unstructured mesh could already be recognized in the aortic arc around the delivery sheath.After the successful deployment of the valve and removal of the delivery system, this unstructured mesh was noticed floating in the descending aorta near the common iliac bifurcation.This mesh was recognized as the previously dilated omnilink elite stent that was silently explanted and dislodged during the valve progression in the aorta.An attempt to retrieve the unstructured stent with a snare through the 18-fr introducer was made.The snare easily captured the stent enabling its extraction.After removal of the stent, a small dissection of the right iliac artery was noticed, but maintaining vessel patency, without compromising the flow so no treatment was performed.The right femoral access closure was performed using the prostar percutaneous vascular closing device.At the 1-year follow-up, the patient was asymptomatic, with normal valve positioning and function and no signs of lower limb ischemia.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.The reported patient effect of a dissection is listed in the omnilink elite® vascular balloon-expandable stent system, electronic instructions for use as a known patient effect of coronary stenting procedures.In this case, it is likely the stent interacted with the transcatheter aortic heart valve, causing the reported material deformation and device damaged by another device, ultimately causing the stent to migrate in the descending aorta near the common iliac bifurcation.An attempt to retrieve the unstructured stent with a snare through the 18-fr introducer was made.The snare easily captured the stent enabling its extraction.After removal of the stent, a small dissection of the right iliac artery was noticed, but maintaining vessel patency, without compromising the flow so no treatment was performed.The investigation determined the reported stent migration, material deformation and device damaged by another device in addition to the subsequent removal of foreign body and unexpected medical intervention (additional therapy/non-surgical treatment) appear to be related to the operational context of the procedure.A conclusive cause for the reported patient effect of vascular dissection, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Type of Device: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16418196
• MDR Text Key: 309977910
• Report Number: 2024168-2023-01768
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK OMNILINK ELITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• 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: Initial
• Patient Sequence Number: 1
• Treatment: 18FR INTRODUCER.; 8FR INTRODUCER.
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male