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

Model Number	1011487-18
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat the left vertebral artery that is 85% stenosed.The 4.0x18mm herculink was advanced over an unspecified.014 guide wire; however, once the herculink was deployed the stent migrated to common interosseous artery and was embedded.There was no adverse patient sequela and no clinically significant delay in the procedure.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.A conclusive cause for the reported stent migration could not be determined; however, the subsequent unexpected medical intervention (additional therapy/non-surgical treatment) and device embedded in tissue or plaque appear to be related to the operational context of the procedure.Factors that may contribute to stent migration include, but are not limited to, patient anatomical morphology, patient disease state, non-uniform or partial stent apposition or under-sizing of the vessel.In this case, it is possible the device may have interacted with the 85% stenosed lesion during stent positioning/deployment, causing the reported stent migration; however, based on the information provided and without the device to examine, a definitive cause for the reported stent migration cannot be determined.The stent was embedded inside the patient anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9 correction: device available for evaluation updated from yes to no.

• 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: 22416018
• Report Number: 2024168-2025-06918
• Device Sequence Number: 15198321
• Product Code: NIN
• UDI-Device Identifier: 08717648077845
• UDI-Public: (01)08717648077845(17)270131(10)4020661
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: 1011487-18
• Device Catalogue Number: 1011487-18
• Device Lot Number: 4020661
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2024
• 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: Other; Required Intervention
• Patient Sex: Unknown