MAUDE Adverse Event Report: ABBOTT VASCULAR INC. Herculink Elite; Stent, Renal

Model Number	1011493-18
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional device referenced in b5 is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure performed was to treat a de novo, mildly calcified, heavily tortuous renal artery that is 90% stenosed.During advancement of the 5.0 x 18 mm herculink elite balloon-expandable stent delivery system (sds) over the 0.014 ht command guide wire, resistance was met and despite repositioning, the sds failed to cross the lesion.Resistance was noted during withdrawal of the stent along the guide wire, resulting in entanglement of the devices.The sds and guide wire were withdrawn smoothly through the sheath.Once outside the anatomy, the stent and balloon were noted to be separated from the whole system.The devices were pulled apart, and the guide wire was intentionally cut in an attempt to remove it from the sds with no success.A new unspecified sds and guide wire were used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.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 -280
• Manufacturer (Section G): ABBOTT VASCULAR, Reg # 2024168; 26531 ynez road; temecula CA 92591 -462
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591--462 ; +1(951)914-5259
• MDR Report Key: 25719924
• Report Number: 2024168-2026-02623
• Device Sequence Number: 17416852
• Product Code: NIN
• UDI-Device Identifier: 08717648078026
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2026

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
• Operator of Device: Health Professional
• Device Model Number: 1011493-18
• Device Catalogue Number: 1011493-18
• Device Lot Number: 5112461
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 07/06/2026
• Supplement Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2025
• 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
• Patient Sex: Unknown