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

Catalog Number 11011-39

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

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

Event Date 11/26/2021

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a left iliac artery.While advancing a 8x39mm omnilink elite 35 delivery system over the guide wire (still outside the patient) resistance was met with the guide wire, then it was noted that the stent implant moved/slid backwards from the balloon.Another 8x39mm omnilink elite was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

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.

Manufacturer Narrative

A visual, dimensional, and functional inspections were performed on the returned sds.The reported stent dislodgement was confirmed.The reported difficulty to advance the sds over the guide wire was unable to be confirmed and a proxy guide wire was able to advance and retract without any resistance noted.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 reported from this lot.Factors that may contribute to the difficulty to advance/position the sds over the guide wire and cause resistance between the devices may include, but not limited to, manufacturing, device placement technique, guiding catheter support, anatomical conditions/patient anatomical morphology, inner diameter of guide wire lumen of sds device, outer diameter of the guide wire, condition of the guide wire, condition of the sds, coagulation of blood or procedural contaminates.Additionally, factors that can contribute to stent dislodgement may include, but not limited to; improper or inadequate crimping at the time of manufacture, incorrect sheath sizing, positive pressure during preparation, forced sheath removal, handling of the stent during preparation, and interaction with the lesion, accessory devices, and/or previously implanted stents.The investigation was unable to determine a conclusive cause for the reported difficulty to advance the sds over the guide wire and stent dislodgement.It is possible that the stent dislodgment occurred during removal of the protective sheath; however, this could not be confirmed.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: 13046887
• MDR Text Key: 284981680
• Report Number: 2024168-2021-11905
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: BU
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

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 Expiration Date: 08/31/2023
• Device Catalogue Number: 11011-39
• Device Lot Number: 0031941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 01/31/2022
• Supplement Dates FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2020
• 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
• Treatment: TERUMO 0.35/300 J STIFF GUIDEWIRE; TERUMO 6F SHEATH
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White