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

Model Number	1011499-18
Medical Device Problem Codes	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	10/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the renal artery with mild calcification and 80% stenosis.The 6x18mm herculink elite stent delivery system (sds) was advanced over a command guide wire, then passed through an unspecified sheath to the target site; however, the sds failed to cross the target lesion due to the anatomy.Therefore, the sds was removed and a flat bend was noted on the stent.A same size herculink sds was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Return device analysis found the stent implant was stationary on the balloon but not between the markers.The struts at the distal end of the stent implant were located 4mm proximal to the proximal edge of the distal marker.The proximal end of the stent implant was located 1mm passed the proximal edge of the proximal balloon marker.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent damage was confirmed.The reported failure to advance 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.Based on the reported information and evaluation of the returned device, it is likely that the failure to advance was due to interaction with the anatomy.Additionally, it is likely that during the attempt to advance against resistance, the stent became compromised on the balloon resulting in the noted damage to the stent and movement on the balloon.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: 21170534
• Report Number: 2024168-2025-00637
• Device Sequence Number: 11896810
• Product Code: NIN
• UDI-Device Identifier: 08717648078200
• UDI-Public: (01)08717648078200(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
• Report Date (Section B): 01/16/2025

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 Model Number: 1011499-18
• Device Catalogue Number: 1011499-18
• Device Lot Number: 4020661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COMMAND GUIDEWIRE
• Patient Sex: Unknown