MAUDE Adverse Event Report: AV-TEMECULA-CT RX HERCULINK ELITE STENT SYSTEM; RENAL STENT SYSTEM

Catalog Number	1011499-18
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual, dimensional and functional inspection was performed on the returned stent.The resistance with the guide wire and tear to the balloon was confirmed.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 revealed no other incidents.The rx herculink elite renal and biliary stent system instructions for use instructs that prior to use, flush the guide wire lumen with normal saline until fluid exits the guide wire exit notch.The difficulties encountered appear to be related to failing to flush the guide wire lumen prior to the initial advancement and 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 patient underwent a stenting procedure to treat a target lesion in the right renal artery.The herculink elite stent delivery system was not flushed prior to use, and when advanced over the spartacore guide wire, resistance was felt.The device was removed from the guide wire with difficulty, and the end of the guide wire kinked.In order to remove the herculink elite and maintain vessel access, the kinked end of the guide wire was cut off.The herculink was easily removed from the guide wire.The herculink elite was flushed and was advanced over the same guide wire; however, when the guide wire was cut, a burr occurred at the cut end.The burr caused a tear in the herculink elite delivery system balloon and the device was removed from the guide wire without resistance.A second herculink elite stent delivery system was then prepared, and was flushed appropriately.The device was advanced over the same cut spartacore guide wire without difficulty and the stent was successfully implanted.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Common Device Name: RENAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6589843
• Report Number: 2024168-2017-04464
• Device Sequence Number: 788788
• Product Code: NIN
• UDI-Device Identifier: 08717648078200
• UDI-Public: (01)08717648078200(17)200229(10)7031461
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2017

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: 02/29/2020
• Device Catalogue Number: 1011499-18
• Device Lot Number: 7031461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 65