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

Catalog Number	1012633-39
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the calcified common iliac artery.The 10x39 mm omnilink elite stent delivery system (sds) was advanced to the lesion and deployment was attempted.The balloon inflated; however, the stent did not deploy at all.The sds with the stent still on the balloon was removed from the anatomy and another omnilink elite sds was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
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 to treat the calcified common iliac artery.The 10x39 mm omnilink elite stent delivery system (sds) was advanced to the lesion and deployment was attempted.The balloon inflated; however, the stent did not deploy at all.The sds with the stent still on the balloon was removed from the anatomy and another omnilink elite sds was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.Returned device analysis identified that the stent had moved on the delivery system.The account was aware of the dislodgement but did not know if it occurred during advancement or removal.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 activation failure 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, stent dislodgement may be attributed to several factors including, 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 accessory devices.Factors that may contribute to activation failures including expansion failures include, but are not limited to, inflation technique, contrast concentration, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.In this case, it is possible that interaction with the challenging anatomy during advancement may have contributed to the observed material deformation (stretched and bent struts) in addition to the reported stent dislodgement, ultimately causing the reported activation failure; 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 PERIPHERAL STENT SYSTEM
• Common Device Name: 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: 19281513
• Report Number: 2024168-2024-05715
• Device Sequence Number: 7577707
• Product Code: NIO
• UDI-Device Identifier: 08717648178597
• UDI-Public: (01)08717648178597(17)260930(10)3040641
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/18/2024

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: 09/30/2026
• Device Catalogue Number: 1012633-39
• Device Lot Number: 3040641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• 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