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

Model Number	1012630-39
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat the left iliac artery with calcification and 70% stenosis.Intravascular ultrasound was performed and a 6fr 10 cm sheath was used.The 7.0x39 mm omnilink elite stent delivery system (sds) was inflated to nominal pressure and it was thought to have deployed the stent; however, something was noticed floating in the aorta and it was determined to be the stent.The stent dislodged [migrated] into the aorta once deflation was completed.There were no issues noted during inflation or deflation and there was no resistance during advancement.A snare was used to retrieve the stent from the aorta thru the other groin.Another omnilink elite sds was used to complete the procedure.There were no adverse patient sequela and there was a delay in the procedure, but there was no impact to the patient.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned stent.The reported stent migration could not be evaluated as the exact anatomical conditions encountered by the device used during the procedure could not be replicated in the test laboratory.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The investigation was unable to determine a conclusive cause for the reported stent migration; however, factors that may contribute to stent migration include, but are not limited to, patient anatomical morphology, patient disease state, non-uniform or partial stent apposition or under-sizing of the vessel.In this case, it is possible that the patient disease state (moderately calcified, mildly tortuous and 70% stenosed) caused the stent to dislodge and migrate from where it was originally placed in the lesion into the aorta; however, this cannot be confirmed.A snare was used to retrieve the stent from the aorta through the other groin, which likely contributed to the observed material deformation (stretched stent).The subsequent treatment and removal of foreign body 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; therefore, no product-related corrective action will be implemented in this case.

• 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: 15432671
• Report Number: 2024168-2022-09773
• Device Sequence Number: 5845391
• Product Code: NIO
• UDI-Device Identifier: 08717648178474
• UDI-Public: 08717648178474
• 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): 10/12/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 1012630-39
• Device Catalogue Number: 1012630-39
• Device Lot Number: 1072741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6FR 10 CM SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 44 KG