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

Catalog Number	1012623-16
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Numbness (2415)
Date of Event	11/05/2014
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.Date of event is estimated.The device was not returned for evaluation.The reported patient effects of hypersensitivity and pain is a known observed and potential patient effects as listed in the omnilink elite instructions for use.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 information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined and the treatment appears to be related to the circumstances of the procedure.The additional omnilink elites and the absolute pro referenced are being filed under separate medwatch reports.
Event or Problem Description
It was reported the patient had three omni elite and one absolute pro stents implanted in the right common iliac and left common iliac arteries on (b)(6) 2013.Approximately a year later, the patient started experiencing tingling and severe pain down both legs.Medication has been prescribed.The patient has always been sensitive to metal; therefore, an allergy kit has been requested by the allergist.Additionally, the patient suffers of an occlusive peripheral disease.No additional information was provided.

• 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: 6182659
• Report Number: 2024168-2016-08962
• Device Sequence Number: 976174
• Product Code: NIO
• UDI-Device Identifier: 08717648179235
• UDI-Public: (01)08717648179235(17)151031(10)2052841
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2016

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: 10/31/2015
• Device Catalogue Number: 1012623-16
• Device Lot Number: 2052841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2016
• Initial Report FDA Received Date: 12/16/2016
• 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: STENT: OTW OMNILINK ELITE (X2), ABSOLUTE PRO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 59