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

Catalog Number 1011490-12

Device Problems Inflation Problem (1310); Off-Label Use (1494)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a de novo lesion in a mid right vertebral artery that was narrow and eccentric and was 90% stenosed.A 4.5 x 12 mm herculink elite balloon expandable stent system was used; however, the balloon only partially inflated even after several attempts were made.Therefore, another 4.5 x 12 mm herculink elite stent was implanted to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: a visual and functional inspection was performed on the returned stent.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 lot revealed no other incidents.The inflation issue was not confirmed.It was reported that the rx herculink elite was being used to treat an arterial vertebral.The rx herculink elite instruction for use (ifu), states: the rx herculink elite peripheral stent system is intended to open lumen restrictions in the biliary tree, renal arteries, and protected peripheral arteries.In this case, it could not be determined if using the device off-label contributed to the inflation difficulty.The investigation determined that the reported difficulties were due to case circumstances.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 RENAL STENT SYSTEM
• Type of Device: STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8623644
• MDR Text Key: 145499903
• Report Number: 2024168-2019-03930
• Device Sequence Number: 1
• Product Code: NIN
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 1011490-12
• Device Lot Number: 8050461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/20/2019
• Supplement Dates Manufacturer Received: 06/27/2019
• Supplement Dates FDA Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1