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

Catalog Number 11012-29

Device Problems Difficult to Remove (1528); Stretched (1601)

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

Event Date 07/12/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion in the internal carotid artery with moderate calcification and mild tortuosity.The 9.0x29mm omnilink elite 35 stent delivery system was successfully implanted, however, there was resistance with the introducer sheath and the delivery catheter got stuck during removal.The sheath and delivery catheter were removed together as a unit.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The stent remains in patient and the delivery system is returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported stretched (inner member) was confirmed.The reported difficult to remove could not be tested due to the device condition.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 from this lot.The investigation was unable to determine a conclusive cause for the reported difficult to remove; however, the reported stretched inner member appears to be related to the operational context of the procedure.Factors that may contribute to a difficult to remove with the introducer sheath include, but are not limited to, inner diameter of the introducer sheath, outer diameter of the stent delivery system (sds), buildup of procedure contaminants, and/or damage to the introducer sheath or sds.Based on the information provided and the condition of the returned device, it is unknown what may have caused the reported difficult to remove (introducer sheath).Additionally, it is likely that manipulation of the sds during its interaction with the introducer sheath likely resulted in the reported stretched inner member, noted stretched outer member, and noted wrinkled inner/outer member.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that the procedure was to treat a lesion in the internal carotid artery with moderate calcification and mild tortuosity.The 9.0x29mm omnilink elite 35 stent delivery system was successfully implanted, however, there was resistance with the introducer sheath and the delivery catheter got stuck during removal.The sheath and delivery catheter were removed together as a unit.There was no adverse patient effect and there was no clinically significant delay in the procedure.Returned analysis identified the inner member and outer member were stretched and wrinkled proximal to the proximal end of the non-abbott introducer sheath for a length of 1.1cm.The account confirmed there was stretching prior to returning.No additional information was provided.

• 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: 15122766
• MDR Text Key: 301973846
• Report Number: 2024168-2022-08294
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/13/2022

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 Catalogue Number: 11012-29
• Device Lot Number: 2031541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2022
• 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: 6F SHEATH.; WORKHORSE WIRE.