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

Model Number	1011493-18
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the renal artery with heavy calcification and moderate tortuosity.The 5 x 18 mm herculink stent delivery system (sds) met resistance during advancement with the guiding catheter and tortuous anatomy.The stent dislodged from the delivery system.A second guide wire and a balloon were advanced and the balloon was inflated to get all of the device out of the anatomy.Another herculink stent was used to complete the procedure via the left radial access.Final patient outcome was successful.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.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the subsequent unexpected medical intervention appears to be related to circumstances of the procedure.Stent dislodgement may be attributed to several factors including, but not limited to, positive pressure during preparation, forced sheath removal, handling of the stent during preparation, interaction with the anatomy, or interaction with accessory devices.Factors that could contribute to difficult to advance include, but are not limited to, patient anatomical morphology, inner lumen obstruction, patient disease state, pre-dilatation strategy, device placement technique, interaction with previously placed stents or accessory devices.In this case, it is possible the device may have interacted with the heavily calcified, moderately tortuous lesion in addition to accessory devices (guide catheter) during advancement, as resistance was noted, causing the reported difficult to advance, ultimately contributing to the reported stent dislodgement; however, without the device to examine, this cannot be confirmed.A second guide wire and a balloon were advanced, and the balloon was inflated to get all the device out of the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• 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: 25361092
• Report Number: 2024168-2026-02226
• Device Sequence Number: 18804137
• Product Code: NIN
• UDI-Device Identifier: 08717648078026
• UDI-Public: (01)08717648078026(17)270630(10)4071661
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1011493-18
• Device Catalogue Number: 1011493-18
• Device Lot Number: 4071661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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