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

Catalog Number	1012622-59
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Thrombosis (2100)
Date of Event	10/18/2017
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.There was no reported device malfunction and the product was not returned.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 effects of pain, hematoma and thrombosis are known observed and potential patient effects as listed in the omnilink elite instructions for use.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.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional omnilink elite referenced is being filed under a separate medwatch report.
Event or Problem Description
It was reported that on (b)(6) 2017 the patient had undergone previous intervention during which two 6.0 mm/59 mm omnilink elite vascular stents were deployed in the common iliac without issue.On (b)(6) 2017, the patient underwent angiography due to complaints of pain in the stomach area.Angiography revealed thrombosis in both omnilink stents.Thrombolysis was performed on (b)(6) 2017 to remove the thrombosis; however, some thrombosis remained.On (b)(6) 2017, two non-abbott stents were implanted inside the omnilink stents for treatment.The patient experienced a hematoma from the thrombolysis, but otherwise is reported to be fine.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: 7014183
• Report Number: 2024168-2017-08832
• Device Sequence Number: 156322
• Product Code: NIO
• UDI-Device Identifier: 08717648179211
• UDI-Public: 08717648179211
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2017

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: 01/31/2021
• Device Catalogue Number: 1012622-59
• Device Lot Number: 7080241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 11/09/2017
• 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: 6.0MM/59MM OMNILINK ELITE; STENT: 6.0MM/59MM OMNILINK ELITE; STENT: 6.0MM/59MM OMNILINK ELITE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention