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

Model Number	1011487-15
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that out of packaging, the 4.0x15mm rx herculink elite stent delivery system was prepped before the sheath/stylet removal.Resistance was met during removal of the sheath/stylet.The stent was loose and dislodged from the balloon.There was no patient involvement.No additional information was provided.
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 out of packaging, the 4.0x15mm rx herculink elite stent delivery system was prepped before the sheath/stylet removal.It should be noted that the rx herculink elite peripheral stent system instruction for use lists packaging removal steps for sheath removal prior to delivery system preparation.In this case, it is unknown if the instruction for use (ifu) deviation related to stent preparation prior to sheath removal contributed to the reported event.Based on the information provided, a definitive cause for the reported issue could not be determined.Factors that may contribute to difficulty to remove (sheath/stylet) include, but are not limited to, incorrect stylet used, incorrect sheath used, and user mis-handling.In this case, it is possible that the instructions for use deviation related to device preparation prior to sheath removal contributed to the reported difficulties; however, this could not be confirmed.Based on the information provided, a definitive cause for the reported difficulty to remove cannot be determined.The reported stent dislodgement appears to be related to operational context as handling during the difficult removal likely caused the reported stent dislodgement.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 medical device problem code: 2017 - failure to follow steps / instructions.

• 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: 50674579
• Report Number: 2024168-2026-03476
• Device Sequence Number: 12091081
• Product Code: NIN
• UDI-Device Identifier: 08717648077838
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 1011487-15
• Device Catalogue Number: 1011487-15
• Device Lot Number: 4021561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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
• Patient Sex: Unknown