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

Model Number	1012630-29
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
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.Na.
Event or Problem Description
It was reported the procedure was to treat a severely tortuous and mildly calcified lesion in the iliac artery.The 7.0x29mm omnilink elite stent delivery system (sds) was advanced however failed to cross the lesion.During retraction, the stent struts became flared and interacted with the 6fr sheath, causing resistance.The sds was able to be retracted into the sheath and removed from the anatomy.An absolute pro stent was used to complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
Visual, dimensional and functional analysis was performed on the return device.The reported stent damage was confirmed.The failure to advance and difficulty removing could not be tested as it was based on the circumstances of the procedure.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 similar incidents and/or complaints from this lot.Based on the information provided, the reported difficulties appear to be due to case circumstances.The failure to advance was likely due to interaction with the anatomy.Additionally, during withdrawal, the proximal stent struts likely interacted with the distal end of the introducer sheath causing the struts to flare resulting in resistance with the sheath during removal.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 9863176
• Report Number: 2024168-2020-02770
• Device Sequence Number: 11493229
• Product Code: NIO
• UDI-Device Identifier: 08717648178467
• UDI-Public: 08717648178467
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 04/03/2020

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: 04/30/2022
• Device Model Number: 1012630-29
• Device Catalogue Number: 1012630-29
• Device Lot Number: 8110141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6FR SHEATH; 6FR SHEATH
• Patient Age: 77 YR