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

Model Number	1012631-29
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, the 8.0x29mm otw omnilink elite balloon was prepped prior to removal of the protective sheath; however resistance was then met when attempting to remove the sheath.When the protective sheath was able to be removed, the stent came off the balloon.The device was not used in the patient and the procedure was completed with another non-abbott device.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code 2017 clarifier- incorrect prep manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported difficult to remove 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.It was reported that during preparation, the 8.0x29mm otw omnilink elite balloon was prepped prior to removal of the protective sheath.It should be noted that the omnilink elite instructions for use: remove the protective cover from the tip.Attach the syringe with hepns to the guide wire port.Flush until fluid exits the distal tip.Prepare an inflation device / syringe with diluted contrast medium.Attach an inflation device / syringe to the stopcock; attach to the inflation port.With the tip down, orient the delivery system vertically.Open the stopcock to delivery system; pull negative for 30 seconds; release to neutral for contrast fill.Close the stopcock to the delivery system; purge the inflation device / syringe of all air.Repeat steps until all air is expelled.In this case, it is unknown the ifu deviation contributed to the reported event.A conclusive cause for the reported difficulties 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.Factors that can contribute to difficult to remove (sheath/stylet) include, but are not limited to, kinks, bends, procedural technique, damage during manufacturing, or inadvertent mishandling during unpackaging.In this case, it is possible that inadvertent mishandling during protective sheath/stylet removal, as resistance was noted, may have resulted in the reported difficult to remove, 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: 19436285
• Report Number: 2024168-2024-06439
• Device Sequence Number: 18199639
• Product Code: NIO
• UDI-Device Identifier: 08717648178504
• UDI-Public: (01)08717648178504(17)261031(10)3051641
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/16/2024

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 Model Number: 1012631-29
• Device Catalogue Number: 1012631-29
• Device Lot Number: 3051641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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