MAUDE Adverse Event Report: ABBOTT VASCULAR INC. OMNILINK ELITE; STENT, ILIAC

Model Number	1012624-39
Medical Device Problem Codes	Difficult to Insert (1316); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the right common iliac artery.Reportedly difficulty was met inserting the 8x39mm otw omnilink elite balloon expandable stent (bes) into the 6 x 23 non-abbott sheath, and after further inspection it was noted that the stent had become dislodged and was located on the shaft of the catheter.Another omnilink bes was used, and the procedure was completed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported difficult to insert could not be tested due to the condition of the returned device.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other complaints.A conclusive cause for the reported difficulties could not be determined; however, factors that may contribute to stent dislodgment include, but are not limited to, crimping during manufacturing, incorrect sheath sizing, negative pressure during sheath removal, forced sheath removal, mishandling during product preparation for use, or interaction with accessory devices.Factors which may contribute to difficulty inserting the device in the introducer sheath include, but are not limited to, damage to the stent, damage to the guiding catheter, guiding catheter size selection or procedural technique (devices not properly supported or coaxially aligned).In this case, it is possible that the stent may have interacted with the introducer sheath during insertion, causing the observed material deformation (overlapping/lifted stent struts and bent stent) which contributed to the reported difficult to insert, ultimately causing the reported stent dislodgement; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: OMNILINK ELITE
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 19844548
• Report Number: 2024168-2024-08916
• Device Sequence Number: 6597885
• Product Code: NIO
• UDI-Device Identifier: 08717648179303
• UDI-Public: (01)08717648179303(17)250131(10)1081941
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 1012624-39
• Device Catalogue Number: 1012624-39
• Device Lot Number: 1081941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: White