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

Catalog Number 11005-39

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

Patient Problem Foreign Body In Patient (2687)

Event Date 02/16/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents.The investigation was unable to determine a conclusive cause for the reported stent dislodgement; however, the subsequent treatment and foreign body in patient appear to be related to the operational context of the procedure.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 right external iliac artery.A short introducer sheath was positioned.During advancement of the 9.0x39mmx80cm over the wire (otw) omni elite 35 balloon-expandable stent (bes), through the short introducer, to the right external iliac artery, the stent dislodged at the iliac bifurcation due to resistance with the angulation of the bifurcation and because a short introducer sheath was used.The preferred long introducer sheath was not available, so the short one was used.The stent migrated through the vasculature and could not be snared out; therefore, it remains free floating and unsecured in the deep femoral artery.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.An 8x29mmx80cm non-abbott stent was implanted to treat the right external iliac, successfully competing the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction due to resistance with the angulation of the bifurcation and because a short introducer sheath was used resulted in the reported difficult to advance and ultimately resulted in the reported stent dislodgement.The subsequent treatment including foreign body in patient appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B5 - correction for supplemental mdr.H6 - investigation conclusions code 67 (no problem found) was removed and replaced with code 4311 (adverse event related to procedure).H10 - additional mfg narrative: revised.

Event Description

Subsequent to the previously filed report, the following correction was made: a 8x29mmx80cm omnilink elite stent was implanted to successfully complete the procedure.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: 16518448
• MDR Text Key: 311035644
• Report Number: 2024168-2023-02495
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: GP
• 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: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11005-39
• Device Lot Number: 2090541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/09/2023
• Supplement Dates Manufacturer Received: 04/07/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2022
• 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: 7F SHORT INTRODUCER; OLE 8X29X80
• Patient Outcome(s): Required Intervention