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

Model Number	1012624-29
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a concentric, heavily calcified, moderately tortuous, de novo superior mesenteric artery (sma).An 8x29mm omnilink elite vascular balloon-expandable stent system (bes) was advanced through the guide catheter, but as it was exiting the guide catheter into the vessel, resistance was noted and angiography confirmed the stent was loose on the balloon.Due to the possibility of a stent dislodgement, the balloon was slightly inflated to hold the stent, and the stent and the guiding catheter were removed as a single unit without issue.There was no adverse patient effect or a clinically significant delay in the procedure.A 7x29mm omnilink bes was implanted to successfully complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device and the reported stent dislodgment was confirmed.The reported difficulty to advance through the guiding sheath was unable to be confirmed due to the returned condition of the device.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 reported from this lot.It should be noted that per the instructions for use (ifu) peripheral stent system omnilink elite states: the omnilink elite peripheral stent system is indicated for the treatment of de novo or restenotic atherosclerotic lesions in protected peripheral arteries and palliation of malignant strictures in the biliary tree.In this case, the violation of the instructions for use (wrong anatomy) does not appear to have caused or contributed to the reported difficulties.There was no damage noted to the sds during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported difficulty to advance, and stent dislodgement appear to be related to operational circumstances of the procedure.Based on the reported information, the stent delivery system (sds) encountered resistance while exiting the guiding sheath.It is likely that the heavily calcified, moderately tortuous anatomy caused the reported resistance and did not allow the sds to exit the guiding sheath resulting in the stent dislodgment but remained on the balloon.Manipulation against resistance during retraction ultimately resulted in the stent dislodgement off the balloon and subsequent noted damages to the stent.There were crimp marks noted on the balloon which suggest that the stent was originally positioned correctly and securely at the time of manufacture.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: 10961783
• Report Number: 2024168-2020-10232
• Device Sequence Number: 583793
• Product Code: NIO
• UDI-Device Identifier: 08717648179297
• UDI-Public: 08717648179297
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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: 12/31/2022
• Device Model Number: 1012624-29
• Device Catalogue Number: 1012624-29
• Device Lot Number: 9070841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1