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

Catalog Number	1012630-29
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for evaluation.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.Based on the information provided, the reported difficulties appear to be due to case circumstances.It is likely that after the failed attempt to advance, the stent became loosened on the balloon due to interaction with the anatomy, resulting in the dislodgment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The device was discarded.
Event or Problem Description
It was reported that the 7.0x29 mm omnilink elite stent delivery system (sds) met resistance with the tortuous anatomy during advancement to the superior mesenteric artery (sma).The sma was accessed via the right groin.Due to the tortuosity, the stent dislodged from the sds and remained in the aorta.A snare was inserted through the left groin and the stent was removed from the aorta without difficulty.The sma was treated with balloon angioplasty only.There were no adverse patient effects and no clinically significant delay in the procedure.

• 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: 9272708
• Report Number: 2024168-2019-13156
• Device Sequence Number: 1646262
• Product Code: NIO
• UDI-Device Identifier: 08717648178467
• UDI-Public: 08717648178467
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1012630-29
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention