MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HERCULINK ELITE; STENT, RENAL

Model Number	1011493-15
Medical Device Problem Codes	Off-Label Use (1494); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified and mildly tortuous lesion in the left vertebral artery.A 5x15mm herculink elite balloon expandable stent (bes) was advanced to the lesion over a 2m non-abbott guidewire; however, the stent was noted to become dislodged.A non-abbott balloon catheter was used to fully expand the dislodged stent in the target lesion and a 4x20mm viatrac balloon dilatation catheter was used to post-dilate the stent.Another same sized herculink was then deployed at the distal end of the stent completing the procedure.There were no adverse patient sequela and no reported clinical delay.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 1494 - incorrect anatomy.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.It was reported that the procedure was performed to treat a moderately calcified and mildly tortuous lesion in the left vertebral artery.It should be noted that the rx herculink elite peripheral stent system instructions for use (ifu), (indications for use) specifies: the rx herculink elite¿ peripheral stent system is indicated for improving arterial luminal diameter in patients with atherosclerotic lesions in renal arteries.It is unknown if the ifu deviation(s) directly caused or contributed to the reported event.Based on the reported information, it is likely that the stent dislodgment was due to interaction with the challenging anatomy.As a result, unexpected medical intervention was required using a non-abbott balloon catheter to fully expand the dislodged stent in the target lesion and a 4x20mm viatrac balloon dilatation catheter was used to post-dilate the stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified and mildly tortuous lesion in the left vertebral artery.A 5x15mm herculink elite balloon expandable stent (bes) was advanced to the lesion over a 2 meter non-abbott guidewire; however, the stent was noted to become dislodged.A non-abbott balloon catheter was used to fully expand the dislodged stent in the target lesion and a 4x20mm viatrac balloon dilatation catheter was used to post-dilate the stent.Another same sized herculink elite stent was then deployed at the distal end of the deployed stent completing the procedure.There were no adverse patient sequela and no reported clinical delay.No additional information was provided.

• Brand Name: HERCULINK ELITE
• Common Device Name: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20986868
• Report Number: 2024168-2024-15130
• Device Sequence Number: 7788194
• Product Code: NIN
• UDI-Device Identifier: 08717648078019
• UDI-Public: (01)08717648078019(17)270131(10)4020861
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1011493-15
• Device Catalogue Number: 1011493-15
• Device Lot Number: 4020861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown