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

Model Number	1012631-59
Medical Device Problem Codes	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	11/12/2021
Type of Reportable Event	Malfunction
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 performed to treat a lesion with no tortuosity and heavy calcification in the right common iliac artery.Pre-dilatation was performed successfully.The 8.0 x 59 mm otw omni elite stent delivery system (cds) was advanced to the target lesion, but once at the lesion the stent could not be seen under fluoroscopy.The sds was removed, and it was noted that there was no stent on the balloon.The stent was found on the back table.It was suspected it might have dislodged during preparation of the sds and not noticed.A new sds was used successfully in the procedure.There was no adverse patient effect 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 and the reported stent dislodgement was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the review of similar incident(s) there is no indication of a lot specific product quality issue.The investigation determined the stent dislodgement appear to be related to case circumstances of the procedure.Based on the reported information, it is likely that the stent implant was inadvertently pulled off during removal of the protective sheath.As there were visible crimp marks noted on the balloon between the markers, this suggests that the stent was originally positioned correctly and securely at the time of manufacture.The noted stent damages likely occurred during packing for return analysis.It should be noted that per instructions for use peripheral stent system omnilink elite states: do not remove stent from its delivery balloon, as removal may damage the stent and / or to stent embolization.Carefully inspect the omnilink elite stent system prior to use to verify that the stent has not been damaged in shipment and that the device dimensions are suitable for the specific procedure.Take care to avoid unnecessary handling.In this case, although the device was not inspected prior to use, use of the device without the stent did not cause or contribute to any device malfunctions or adverse patient effect.There is no indication of a product quality issue with respect to the design, manufacture.

• 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: 12934594
• Report Number: 2024168-2021-11088
• Device Sequence Number: 20030464
• Product Code: NIO
• UDI-Device Identifier: 08717648178528
• UDI-Public: 08717648178528
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 12/29/2021

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: 08/31/2024
• Device Model Number: 1012631-59
• Device Catalogue Number: 1012631-59
• Device Lot Number: 1030841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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