MAUDE Adverse Event Report: AV-TEMECULA-CT OMNILINK ELITE PERIPHERAL STENT SYSTEM

Catalog Number	1012622-19
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Rash (2033)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Estimated date.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.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effect of allergic reaction is listed in the otw omnilink elite instructions for use 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.
Event or Problem Description
It was reported that the procedure was performed on (b)(6) 2018 to treat a lesion in the superior mesenteric artery.A 6.0mmx19mmx80cm omni elite stent was implanted without issue.The patient was started on plavix on (b)(6) 2018.Two or three weeks after the procedure (date unknown), the patient developed a rash, itching and hives throughout the body.The patient saw her primary doctor and the patient was given prednisone and hydroxyzine.The physician informed the patient the reaction she is having does not appear to be related to an antibiotic she is taking for dental treatment performed after the stent implant procedure.The patient was taking the antibiotic from (b)(6) to (b)(6).The patient will see an allergist and dermatologist this week.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).It was reported that the procedure was performed to treat a lesion in the superior mesenteric artery.The instructions for use states: the omnilink elite stent system is indicated for the treatment of atherosclerotic iliac artery lesions.Although the device was used off-label, there does not appear to be any relation to the reported patient effects.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Common Device Name: PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7882803
• Report Number: 2024168-2018-07219
• Device Sequence Number: 2508312
• Product Code: NIO
• UDI-Device Identifier: 08717648179181
• UDI-Public: 08717648179181
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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: 06/30/2020
• Device Catalogue Number: 1012622-19
• Device Lot Number: 7011841
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 09/25/2018
• 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: 82 YR
• Patient Weight: 73