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

Catalog Number	1012626-59
Medical Device Problem Codes	Difficult to Advance (2920); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device was not returned for evaluation.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 indication of a lot specific product quality issue.Based on the information provided, the reported difficulties appear to be due to case circumstances.The resistance during advancement was due to the interaction with the heavily calcified anatomy.Additionally, it is likely that the that challenging anatomy contributed to the deployment failure.It is likely that the balloon was unable to expand, as it was reported that additional pre-dilatation was performed and a second omnilink elite was used without issue, indicating that anatomy contribute to difficulty.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the heavily calcified iliac artery.The 10.0 x 59 mm omnilink elite stent delivery system (sds) was advanced, with resistance, to the target lesion.The sds balloon was attempted to be inflated, but the stent remained on the stent delivery system.The sds was removed without resistance and the stent remained on the delivery system.Additional predilatation was performed and a second omnilink elite was used without issue.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

• Brand Name: OMNILINK ELITE
• Common Device Name: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9434299
• Report Number: 2024168-2019-14264
• Device Sequence Number: 2424821
• Product Code: NIO
• UDI-Device Identifier: 08717648179396
• UDI-Public: 08717648179396
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2019

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: 01/31/2021
• Device Catalogue Number: 1012626-59
• Device Lot Number: 7081841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1