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

Model Number	1011505-15
Medical Device Problem Codes	Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
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 of specific issue.Based on the information provided, a definitive cause for the reported malposition and wall apposition could not be determined.The reported difficulty to remove the guide wire due to interaction with the herculink stent and subsequent treatments appear to be related operational context of the procedure.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.
Event or Problem Description
It was reported that the procedure performed was to treat a left renal artery that is 95% stenosed.During deployment of a 7.0x15mm herculink elite ballon-expandable stent (bes), the stent successfully deployed at 14 atmospheres, but missed the target lesion and was not fully apposed to the vessel wall.A second 6.0x12mm herculink stent was deployed at 14 atmospheres and successfully implanted at the target lesion.The 6.0x12 herculink balloon was completely deflated and during removal of the stent delivery system, the 7.0x15mm herculink bes was moved to the distal renal artery due to movement of an unspecified guide wire.A 7x40mm jade balloon was used to post dilate the 6x12mm bes.The same 7x40mm jade balloon was used to embed the 7.0x15mm herculink bes into the distal renal artery.There was no adverse patient sequela and no clinically significant delay in 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 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: 22739981
• Report Number: 2024168-2025-08192
• Device Sequence Number: 7218268
• Product Code: NIN
• UDI-Device Identifier: 08717648078378
• UDI-Public: (01)08717648078378(17)261231(10)4011061
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/07/2025

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: 1011505-15
• Device Catalogue Number: 1011505-15
• Device Lot Number: 4011061
• 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: 07/14/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2024
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 62 KG