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

Model Number	1011493-18
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This will be filed.It was reported the 5.0x18mm rx herculink elite stent delivery system (sds) was advanced however failed to cross the lesion.During removal the stent struts caught on the sheath, causing the struts to bend.There were no adverse patient effects.Difficult to remove devices do not necessarily indicate a device malfunction and may be the result of challenging anatomical conditions/lesions.However, it has led to the following types of adverse patient impacts: surgical removal, separations of device components, vessel dissection or perforation, medical intervention (snare), foreign body not retrieved.Therefore, even in the absence of a device malfunction and if the device was ultimately removed without patient impact, all difficult to remove devices will be reportable.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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 difficulties could not be determined.Factors that could contribute to failure to advance include, but are not limited to, patient anatomical morphology, patient disease state, pre-dilatation strategy, device placement technique, interaction with previously placed stents or accessory devices.Factors that can contribute to difficult to remove include, but are not limited to, kinks, bends, procedural technique, insufficient support, or interactions with other devices.Factors that could contribute to material deformation include, but are not limited to, inadvertent mishandling during sheath/stylet removal, preparation, during use of the device, or interaction with anatomy or accessory devices.In this case, it is possible the device may have interacted with the tortuous and stenosed lesion during advancement, causing the reported failure to advance.Interaction with the sheath during removal of the device may have contributed to the reported material deformation, ultimately causing the reported difficult to remove; however, based on the information provided and without the device to examine, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported material deformation was confirmed.The reported failure to advance could not be evaluated as the exact anatomical conditions encountered by the device used during the procedure could not be replicated in the test laboratory.The reported difficult to remove could not be tested due to the condition of the returned device.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 difficulties could not be determined.Factors that could contribute to failure to advance include, but are not limited to, patient anatomical morphology, patient disease state, pre-dilatation strategy, device placement technique, interaction with previously placed stents or accessory devices.Factors that can contribute to difficult to remove include, but are not limited to, kinks, bends, procedural technique, insufficient support, or interactions with other devices.Factors that could contribute to material deformation include, but are not limited to, inadvertent mishandling during sheath/stylet removal, preparation, during use of the device, or interaction with anatomy or accessory devices.In this case, it is possible the device may have interacted with the tortuous and stenosed lesion during advancement, causing the reported failure to advance.Interaction with the sheath during removal of the device may have contributed to the reported material deformation, ultimately causing the reported difficult to remove; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported the procedure was to treat a tortuous and stenosed lesion in the left renal artery.The 5.0x18mm rx herculink elite stent delivery system (sds) was advanced however failed to cross the lesion.During removal the stent struts caught on the sheath, causing the struts to bend.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: 24019301
• Report Number: 2024168-2026-00179
• Device Sequence Number: 10550107
• Product Code: NIN
• UDI-Device Identifier: 08717648078026
• UDI-Public: (01)08717648078026(17)281031(10)5111461
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup,Followup
• Report Date (Section B): 02/06/2026

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: 1011493-18
• Device Catalogue Number: 1011493-18
• Device Lot Number: 5111461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 02/03/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/19/2026; 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2025
• 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