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

Model Number	1012624-39
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, a definitive cause for the stent dislodgment could not be determined.It may be possible that the stent dislodgment was due to interaction with the tortuous anatomical conditions; however, this could not be confirmed.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 to treat the moderately calcified lesion in the moderately tortuous iliac artery.Reportedly, the 8x39 mm omnilink elite stent delivery system (sds) was being advanced without resistance and the stent dislodged.The sds balloon was inflated right away even though the stent was not in the correct position and the stent was deployed outside the target lesion.A new omnilink elite stent was used to complete the procedure.There were no adverse patient sequela and there was no reported clinically significant delay in the procedure.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: 10094148
• Report Number: 2024168-2020-04540
• Device Sequence Number: 11614844
• Product Code: NIO
• UDI-Device Identifier: 08717648179303
• UDI-Public: 08717648179303
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2020

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: 11/30/2022
• Device Model Number: 1012624-39
• Device Catalogue Number: 1012624-39
• Device Lot Number: 9061241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other