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

Model Number	1012632-19
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot.Overall, without having the device returned to examine, a conclusive cause for the reported difficulty could not be determined.There is no indication of a product quality issue.
Event or Problem Description
It was reported that during device preparation of the omnilink elite stent delivery system, after removal from the dispenser coil and removal of the protective sheath, without resistance, it was noted that the stent came off the balloon.The device was not used and there was no patient involvement.There was no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device and the reported stent dislodgement was confirmed.In this case, based on the returned analysis, it is likely that during preparation, positive pressure was inadvertently applied to the balloon resulting in the reported stent dislodgement.The investigation determined the reported stent dislodgement appears to be related to operational circumstances of the procedure.D10, h3: device available for evaluation h6: method code 4115 - removed.Conclusion code 67 - removed.

• 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: 9782095
• Report Number: 2024168-2020-01967
• Device Sequence Number: 618575
• Product Code: NIO
• UDI-Device Identifier: 08717648178535
• UDI-Public: 08717648178535
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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: 09/30/2022
• Device Model Number: 1012632-19
• Device Catalogue Number: 1012632-19
• Device Lot Number: 9040441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1