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

Catalog Number 11012-39

Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a lesion in the right iliac artery with 70% stenosis and moderate calcification.The 9.0x39mm omnilink elite stent delivery system (sds) could not be inserted into a 6fr (french) introducer sheath despite various attempts.The 6fr introducer sheath and sds were stuck and removed together as a unit.The 6fr introducer sheath was replaced with a 7fr introducer sheath.Another same size omnilink elite stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

Event Description

It was reported that the procedure was to treat a lesion in the right iliac artery with 70% stenosis and moderate calcification.The 9.0x39mm omnilink elite stent delivery system (sds) could not be inserted into a 6fr (french) introducer sheath despite various attempts.The 6fr introducer sheath and sds were stuck and removed together as a unit.The 6fr introducer sheath was replaced with a 7fr introducer sheath.Another same size omnilink elite stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.Returned device analysis identified that the sds was returned with a separation at the smiley shaft located 121.5cm distally from the distal end of the strain relief.The account was aware of the separation and it occurred during the attempt to remove the device from the introducer.No additional information was provided.

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported material separation was confirmed.The reported difficult to advance/position and difficult to remove could not be tested due to the condition of the returned device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The investigation was unable to determine a conclusive cause for the reported difficulties; however, potential causes for a material separation include, but are not limited to, damage during manufacturing, inadvertent mishandling during unpackaging, during preparation or use of the device, interaction with the anatomy and/or accessory devices.Factors which may contribute to difficulty advancing and removing the device in the introducer sheath include, but are not limited to, damage to the stent, damage to the introducer sheath/guiding catheter, introducer sheath/guiding catheter size selection or procedural technique (devices not properly supported or coaxially aligned).In this case, it may be possible that the inner diameter of the introducer sheath was smaller than the recommended diameter of 0.085 inches (2.15 mm) indicated on the omnilink elite product label.It should be noted that there is no specific industry definition of 6f introducer sheath/guide catheter dimensions or what it means to have a product that is 6f compatible.The only guidance the sheath producers have is to make the inner diameter larger than 2.00mm and smaller than 2.33mm.This contrasts with the convention for guiding catheters that have a clear definition of a maximum outer diameter of 2.0mm.The lack of clear industry guidance may be a contributing factor to why there is a broad range of inner diameters found in commercial introducer sheaths.In addition, it is possible that the reported material separation may have occurred during an attempt to remove the device from the introducer sheath; however, this cannot be confirmed.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: 18088629
• MDR Text Key: 327586019
• Report Number: 2024168-2023-12376
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

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 Catalogue Number: 11012-39
• Device Lot Number: 2022841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• 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: 6FR INTRODUCER SHEATH