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

Model Number	1012624-29
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	08/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2019, an omnilink stent was implanted without issue.Approximately 6 months after stent implantation, the patient experienced unspecified symptoms, without skin changes, and continued to have recurrent symptoms at unspecified times.Reportedly, the patient had several implants after the omnilink was implanted.The patient is being seen for a possible allergic reaction, but the test has not yet been performed and a treatment plan has not yet been provided.No additional information was provided.
Additional Manufacturer Narrative
Date of event is estimated as (b)(6) 2019-(b)(6) 2022.The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of allergic reaction is listed in the omnilink elite® vascular balloon-expandable stent system, electronic instructions for use (eifu) as potential allergies to contrast medium, drug, or stent material and; therefore, is a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
Subsequent to the previously filed report, the following information was received: per the physician, so far, no allergy has been proven and is unlikely.As already mentioned, there were repeated recurrences shortly after implantation of the stents.However, as long as an allergy is not confirmed, md does not consider it useful to claim one.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13425866
• Report Number: 2024168-2022-01130
• Device Sequence Number: 12100782
• Product Code: NIO
• UDI-Device Identifier: 08717648179297
• UDI-Public: 08717648179297
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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 Expiration Date: 04/30/2022
• Device Model Number: 1012624-29
• Device Catalogue Number: 1012624-29
• Device Lot Number: 8111241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown