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

Catalog Number	1012624-39
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/13/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device code 1494- incorrect anatomy the device was not returned for evaluation.Review of the finished product electronic lot history record (elhr) for this product could not be reviewed because the product was not returned for evaluation and the lot number was not reported.It should be noted that the instructions for use (ifu) 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.The off-label use does not appear to have influenced this event.The reported patient effect of death is listed in the otw omnilink elite ifu as a known potential complication associated with the use of the device.Based on the case information, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.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 xact stent referenced in b5 and d11 is filed under a separate medwatch report number.Na.
Event or Problem Description
It was reported that on (b)(6) 2019 the omnilink elite stent was implanted in the subclavian artery and the xact stent was implanted in the internal carotid artery.The procedure was completed successfully.Reportedly, 8 days later, the patient expired.The cause of death is reported as unknown.No additional information was 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: 8828885
• Report Number: 2024168-2019-10385
• Device Sequence Number: 2823790
• Product Code: NIO
• UDI-Device Identifier: 08717648179303
• UDI-Public: 08717648179303
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1012624-39
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: XACT CAROTID STENT
• Outcome Attributed to Adverse Event: Death
• Patient Age: 70 YR
• Patient Weight: 74