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

Catalog Number 11006-39

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 10/25/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion in the iliac artery.A 10.0x39mmx80cm omni elite 35 balloon-expandable stent system (bess) was unable to be inserted into a 6f introducer sheath.The 6f sheath was removed and the bess was advanced into a 7f sheath without issue.Once the bess and the 7f sheath were in the iliac artery, it was decided to remove the bess because they wanted better angiogram images than those they already had.When removing the bess, resistance was met with the tip of the 7f introducer sheath.The bess was changed to a non-abbott catheter, but once the non-abbott catheter was in the iliac artery, it was noted that the undeployed stent had dislodged 10cm away in the healthy iliac artery.A snare was used to capture the stent and pull it back to the entrance of the introducer.As expected, the tightening of the snare around the tip of the stent opened the first millimeter of the stent and made it impossible to pull the stent into the introducer.Therefore, it was decided to remove the stent together with the introducer in one movement pulling the introducer with one hand and the snare with the other hand at the same time, having contact of the stent on the tip of the introducer.When passing the arterial wall during removal, some resistance was met with the anatomy due to the first millimeter of the stent being open.Force was applied by pulling hard and the stent was removed; however the access site was torn, and a huge bleed occurred.Manual compression was performed for a long period of time and a hematoma was noted.Instead of being discharged on that day, the patient remained hospitalized, but was discharged the next day with no adverse sequela.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported stent dislodgement was confirmed.The remaining reported difficulties could not be confirmed as they are related to operation circumstances and the catheter chassis was not returned.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 similar incidents.The reported patient effects of hemorrhage and hematoma are listed in the omnilink elite instruction for use (ifu) as known potential patients effects associated with the use of a stent in peripheral arteries and / or biliary tree.It was reported that when removing the bess, resistance was met with the tip of the 7f introducer sheath.The bess was changed to a non-abbott catheter, but once the non-abbott catheter was in the iliac artery, it was noted that the undeployed stent had dislodged, it should be noted that the omnilink elite ifu sates; should unusual resistance be felt at any time during either lesion access, or removal of an undeployed stent, the stent system, wire, and guiding catheter should be removed as a single unit.Although, the ifu violation may have dislodged the stent, this cannot be confirmed.Based on the reported information, a cause for the reported difficulties cannot be determined.It is possible the stent profile was increased prior to insertion (during sheath removal or prep) or during insertion into the 6f introducer causing the difficult to insert, difficult to remove, and subsequently the resistance noted at the sheath ostium that likely indicated the stent dislodgement, however, this could not be confirmed.The patient effects, and treatments are due to the circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 15800914
• MDR Text Key: 303699759
• Report Number: 2024168-2022-11611
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11006-39
• Device Lot Number: 2032841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• 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: 6 FR INTRODUCER FROM TERUMO.; 7 FR TERUMO INTRODUCER.
• Patient Outcome(s): Required Intervention; Hospitalization