MAUDE Adverse Event Report: ABBOTT VASCULAR RX HERCULINK ELITE STENT SYSTEM; STENT, RENAL

Model Number 1011493-18

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that the procedure was to treat a mildly calcified de novo renal artery that is 70% stenosed.A 5.0x18mm rx herculink elite stent delivery system completely failed to deploy.Device was removed and another same size herculink elite was used to successfully complete the procedure.There were no adverse patient effects reported and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported difficulty to deploy was not confirmed.The noted stretch on the guidewire notch is likely due to case circumstances.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.A conclusive cause for the reported deployment failure was unable to be determined as the issue was not confirmed on the returned unit.It may be possible that the inflation device being used was faulty or not properly connected; however, this could not be confirmed.The stretched guidewire notch is likely due to inadvertent mishandling.This damage can occur if an attempt is made to pull the stent delivery system in an opposite direction as the guide wire.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11158010
• MDR Text Key: 226628870
• Report Number: 2024168-2021-00358
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648078026
• UDI-Public: 08717648078026
• Combination Product (y/n): N
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 1011493-18
• Device Catalogue Number: 1011493-18
• Device Lot Number: 9091661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1