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

Model Number	1012624-59
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The stent remains in patient.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 after the procedure it was noted that the 8.00x59 mm omnilink elite stent was expired.There were no other device issues, there were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot or relabeled lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.It should be noted that per electronic instructions for use (eifu) vascular balloon expandable stent system omnilink elite fda states: use the stent system prior to the ¿use by¿ date specified on the package.Although there were no reported device issues or adverse patient effects, in this case, use of the device past the expiration date appears to be related to user error as the expiration date was not verified prior to use.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
• MDR Report Key: 11931606
• Report Number: 2024168-2021-04632
• Device Sequence Number: 4323921
• Product Code: NIO
• UDI-Device Identifier: 08717648179310
• UDI-Public: 08717648179310
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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: 03/31/2021
• Device Model Number: 1012624-59
• Device Catalogue Number: 1012624-59
• Device Lot Number: 7100541
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1