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

Model Number	1012631-39
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
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 procure was performed to treat a lesion in the moderately calcified left common femoral artery following an abdominal aorta aneurysm repair.During preparation of the 8x39mm omnilink elite stent delivery system (sds), no resistance was noted when removing the sds from the dispenser coil or when removing the stylet.It was noted that the stent was noted to be loose on the delivery system therefore it was not used.Another omnilink elite stent was used to complete the procedure.There was no patient involvement and no clinically significant delay in procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initially file report, it was reported that during the procedure, the sds was loaded into the guiding sheath.There was no adverse patient effects.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.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 similar complaints from this lot.A conclusive cause for the reported stent dislodgement could not be determined; however, factors that may contribute to stent dislodgment prior to use 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.In this case, it is possible that inadvertent mishandling during protective sheath/stylet removal and/or while attempting to load the device into the guiding sheath may have contributed to 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; therefore, no product-related corrective action will be implemented in this case.Corrections: b6 - relevant test/laboratory data: updated.B7 - other relevant history: updated.D1 ¿ brand name: updated.D2a ¿ common device name: updated.D3 ¿ name, address 1, city, postal code: updated.H6 - health effect - impact code: code 2645 was removed and code 2199 was added.

• 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: 19559790
• Report Number: 2024168-2024-07345
• Device Sequence Number: 6730691
• Product Code: NIO
• UDI-Device Identifier: 08717648178511
• UDI-Public: (01)08717648178511(17)250228(10)1091741
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/22/2024

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: 02/28/2025
• Device Model Number: 1012631-39
• Device Catalogue Number: 1012631-39
• Device Lot Number: 1091741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2021
• 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 Sex: Unknown