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

Model Number 1011490-15

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.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 complaints reported from this lot.Based on the information provided, a definitive cause for the difficulties could not be determined.Potential causes for failure to inflate resulting in stent expansion failure may include, but are not limited to, damage to the balloon, damage to the inflation lumen, issues with the inflation device or patient anatomical morphology.In this case, the device was not returned for analysis which may have aided in the cause analysis.It may be possible that the distal shaft of the herculink elite was kinked or collapsed in the heavily calcified 95% stenosed lesion preventing inflation; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was performed to treat a 95% stenosed, moderately tortuous, and heavily calcified lesion in the right renal artery.A 4.5x15mm herculink elite balloon-expandable stent system (bess) was advanced to the lesion; however, the balloon failed to inflate, and the stent failed to deploy.The bess was removed without issues and the procedure was successfully completed with a new 4.5x15mm herculink stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported difficulties were not confirmed.Based on the information provided, and analysis of the returned device a definitive cause for the difficulties could not be determined.It may be possible that the distal shaft of the herculink elite was kinked or collapsed in the heavily calcified 95% stenosed lesion preventing inflation; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D10, h3 - it was initially reported that the device would not be returning for analysis; however, the device was returned.H6: method code 4115 removed.Conclusion code 4315 removed.

• 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: 10620883
• MDR Text Key: 209650311
• Report Number: 2024168-2020-08221
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648077920
• UDI-Public: 08717648077920
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 1011490-15
• Device Catalogue Number: 1011490-15
• Device Lot Number: 9110661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1