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

Model Number	1012623-19
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat the external iliac artery.The 7.0x19mm omnilink elite stent was deployed.Post deployment, the physician felt he had placed the stent too high and decided to place an unspecified balloon in the deployed stent and pull down which caused a perforation.The perforation was treated using an unspecified covered stent inside the omnilink stent.There was no adverse patient sequela reported.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned 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.The indications section of the otw omnilink elite 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.In addition, the ifu, also states: great care must be exercised when crossing a newly deployed stent with a guide wire or balloon catheter to avoid disrupting the stent geometry.Based on the case information, the reported perforation appears to be user related.The reported patient effect of perforation is listed in the otw omnilink elite instructions for use (ifu) as a known potential complication associated with the use of the device.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 9611429
• Report Number: 2024168-2020-00803
• Device Sequence Number: 547148
• Product Code: NIO
• UDI-Device Identifier: 08717648179242
• UDI-Public: 08717648179242
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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 Expiration Date: 07/31/2022
• Device Model Number: 1012623-19
• Device Catalogue Number: 1012623-19
• Device Lot Number: 9021141
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 02/12/2020
• 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
• Patient Age: 72 YR