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

Catalog Number	1012629-39
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2018
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.(b)(4).Evaluation summary: a visual and functional inspection was performed on the returned device.The reported hub leak and balloon rupture could not be confirmed as the device inflated and maintained pressure without any leaks noted.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The omnilink elite vascular balloon expandable stent system electronic instructions for use (ifu) states: balloon pressures should be monitored during inflation.Do not exceed rated burst pressure (rbp) as indicated on product label.Use of pressures higher than specified on product label may result in a ruptured balloon with possible vessel damage or perforation.The violation of the ifu does not appear to have contributed to the reported event, as there was no balloon rupture on the returned device.The investigation was unable to determine a conclusive cause for the reported balloon rupture and hub leak issue.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 performed to treat a lesion in the non-tortuous, mildly calcified, iliac artery.During stent deployment, the 6.0 x 39 mm omnilink elite balloon ruptured at 16 atmosphere (atm).Notably, the area near the hub leaked contrast.The delivery system was removed from the anatomy without reported issue.Post dilatation was performed without issue and the procedure was completed.There was no reported adverse patient effect or a clinically significant delay in the procedure.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: 7543337
• Report Number: 2024168-2018-03920
• Device Sequence Number: 19151784
• Product Code: NIO
• UDI-Device Identifier: 08717648179532
• UDI-Public: 08717648179532
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2018

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: 04/30/2020
• Device Catalogue Number: 1012629-39
• Device Lot Number: 6112341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1