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

Model Number	1011505-18
Medical Device Problem Codes	Product Quality Problem (1506); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of the 7.0x18mm rx herculink elite stent delivery system (sds) resistance was met advancing the device over the 0.014 guide wire.A clear film was noted around the stent.Force was required to remove the sds from the guide wire.A new herculink elite was used to complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.Return device analysis noted the proximal end of the stent implant was located 2mm distally from its original crimped position.There are crimp marks noted on the balloon.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported difficult to advance/remove could not be confirmed due to the condition the device was 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.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported issue could not be determined.Factors that may contribute to the difficult advancing and removing the sds from the guide wire may include, but are not limited to, device placement technique, buildup of procedural contaminants in the guide wire lumen, inner diameter of guide wire lumen, condition of the guide wire, or damage to the shaft of the catheter.In this case, a conclusive cause for the reported complaint could not be determined.Additionally, a clear film was observed and reported by the account; however, there was no film visible during visual inspection of the returned device.It is possible that the inner member interacted with the guide wire during the difficult advancement/removal resulting in the observed inner member bunching.The inner member movement (bunching) may have also caused the balloon to bunch and the account may have identified the balloon bunching as a clear film over the stent; however, this cannot be confirmed.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.

• 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: 24910615
• Report Number: 2024168-2026-01582
• Device Sequence Number: 9195984
• Product Code: NIN
• UDI-Device Identifier: 08717648078385
• UDI-Public: (01)08717648078385(17)260731(10)3081461
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/17/2026

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 Expiration Date: 07/31/2026
• Device Model Number: 1011505-18
• Device Catalogue Number: 1011505-18
• Device Lot Number: 3081461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2023
• 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