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

Model Number 1011487-15

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was performed to treat a 65% stenosed, mildly tortuous, and mildly calcified lesion in the left vertebral artery.Following pre-dilatation, an attempt to advance a 4.0x15mm herculink elite balloon expandable stent system (bess) was made; however, it failed to cross.The bess was removed and resistance with the guide catheter was felt.Once outside the anatomy it was noted that the stent struts were lifted/flared.The procedure was successfully completed with a new 4.0x15mm herculink elite stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual, dimensional, and functional analysis was performed on the returned product.The reported failure to advance and difficulty removing from the anatomy was not tested as it was based on procedural circumstances.The stent damage was confirmed.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 indication of a lot specific product quality issue.The investigation determined that the reported difficulties were due to case circumstances.It is likely that anatomical conditions contributed to the reported failure to cross causing the stent to become compromised on the balloon resulting in resistance and damage to the stent during removal into the guide catheter.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 11970305
• MDR Text Key: 263592267
• Report Number: 2024168-2021-04833
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648077838
• UDI-Public: 08717648077838
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 1011487-15
• Device Catalogue Number: 1011487-15
• Device Lot Number: 0101661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Date Manufacturer Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1