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

Model Number	1012624-19
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation as the stent remains implanted.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 related to circumstances of the procedure.It is likely that the omnilink elite stent could not be fully expanded due to the anatomy, thus preventing the non-abbott catheter from being able to advance through the stent.Additionally, if the omnilink elite stent was not fully apposed to the vessel wall, it is likely that the guide wire became trapped within the stent resulting in difficulty removing and unraveling of the guide wire tip coils.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 a stenosed left pulmonary artery.An 8.0x19mm omnilink elite stent was inflated at 14 atmospheres and deployed in the lesion.Then a non-abbott catheter was advanced over the stiff guide wire in order to measure pressure difference of the distal part of the deployed stent; however, the catheter did not advance through the omnilink stent.Therefore, the non-abbott catheter was replaced with another non-abbott catheter; however, that catheter did not advance either.An attempt was made to remove the stiff guide wire; however, the stiff guide wire could not be removed and became unraveled.On the same day, surgical treatment was performed to remove the guide wire.Per the physician, it is possible the omnilink elite stent could not be fully expanded due to the anatomy and the guide wire became trapped in the stent.There was no additional information 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: 9831940
• Report Number: 2024168-2020-02422
• Device Sequence Number: 727667
• Product Code: NIO
• UDI-Device Identifier: 08717648179280
• UDI-Public: 08717648179280
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/13/2020

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: 05/31/2022
• Device Model Number: 1012624-19
• Device Catalogue Number: 1012624-19
• Device Lot Number: 8121141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1