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

Model Number	1011487-15
Medical Device Problem Codes	Off-Label Use (1494); Failure to Advance (2524); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6 medical device problem code: 1494 - incorrect anatomy.A visual inspection was performed on the returned device.The reported stent dislodgement and stent deformation was confirmed.The reported failure to advance could not be replicated in a testing environment as it was related to operational context of the procedure.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 the procedure was to treat a mildly calcified and moderately tortuous lesion in the right vertebral artery.It should be noted that the rx herculink elite peripheral stent system instructions for use specifies: the rx herculink elite¿ peripheral stent system is indicated for improving arterial luminal diameter in patients with atherosclerotic lesions in renal arteries.It is unknown if the ifu deviation directly caused or contributed to the reported event.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported issue appears to be related to circumstances 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 the procedure was to treat a mildly calcified and moderately tortuous lesion in the right vertebral artery.The 9.0x39mm omnilink elite stent was implanted without issue on (b)(6) 2022.The patient returned on (b)(6) 2024 for another procedure.The 4.0x15mm rx herculink elite stent delivery system (sds) was advanced however could not cross through the previously implanted omnilink elite stent.The sds was removed and it was noted the stent was damaged and mislocated on the balloon.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 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: 21546255
• Report Number: 2024168-2025-02410
• Device Sequence Number: 12512463
• Product Code: NIN
• UDI-Device Identifier: 08717648077838
• UDI-Public: (01)08717648077838(17)260831(10)3090561
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: 1011487-15
• Device Catalogue Number: 1011487-15
• Device Lot Number: 3090561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2023
• 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