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

Catalog Number	1012625-19
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous, non-calcified patent ductus arteriosus (pda) that was 30% stenosed for a pediatric patient.A 9.0 x 19mm omnilink elite was advanced to the target lesion.However, the stent shifted proximally from the balloon while attempting to cross in the pulmonary artery.The device was simply withdrawn as a single unit along with the sheath.The procedure was then completed because the site had no additional 9.0 x 19mm omnilink elite in their inventory.There was no clinically significant delay in the procedure and no adverse patient effects.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: 7076727
• Report Number: 2024168-2017-09335
• Device Sequence Number: 1450134
• Product Code: NIO
• UDI-Device Identifier: 08717648179327
• UDI-Public: 08717648179327
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 1012625-19
• Device Lot Number: 5040241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1