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

Catalog Number 11005-39

Device Problems Defective Device (2588); Deformation Due to Compressive Stress (2889); Device Markings/Labelling Problem (2911); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

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

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

Visual, and dimensional analysis was performed on the returned omnilink elite.The reported deformation was confirmed.The failure to advance and device marking problem were not confirmed due to the condition of the device.Additionally, it was noted that the stent implant was stationary on the balloon but dislocated distally and dimensional analysis revealed the crimped stent profiles measured above the maximum crimped stent specification 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 complaints reported from this lot.The investigation was unable to determine conclusive cause for the reported difficulties.The introducer sheath used in this case was not returned; therefore, the exact inner diameter was unable to be determined.However, it may be possible that the inner diameter of the non-abbott introducer sheath was smaller than the recommended sheath diameter of 0.085 inches (2.15mm) indicated on the omnilink elite product label.It should be noted that there is no specific industry definition of 6f sheath dimensions or what it means to have a product that is 6f compatible.Several of the manufacturers label their product with a "generic" 2.0mm labeled specification based on the fact that the definition of 6f is 2mm.However, this does not reflect the actual inner diameter of the sheath.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.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 located in an unspecified vessel.The stent packaging stated that the stent delivery system is compatible with a 6f introducer; however, when advancing the stent delivery system (sds) in a 6f introducer, the sds could not advance.When applying force to attempt to push the stent system, a kink occurred in the shaft and the stent system became unusable.The device was removed without issue.There was no adverse patient effect or a clinically significant delay in procedure.A non-abbott stent was implanted to complete the procedure.Device analysis on (b)(6) 2021 revealed the measured crimped stent profile was higher than the maximum crimped stent profile.Also, the stent implant was stationary on the balloon but dislocated distally to the balloon proximal marker band.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: 11497329
• MDR Text Key: 242175142
• Report Number: 2024168-2021-02072
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2021

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 Expiration Date: 10/31/2023
• Device Catalogue Number: 11005-39
• Device Lot Number: 0050641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2020
• 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