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

Model Number	1011490-15
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6; medical device problem code 1494 clarifier: indication for use.
Event or Problem Description
It was reported that the procedure was to treat the left vertebral artery with mild calcification, mild tortuosity and 90% stenosis.The 4.5x15 mm herculink elite stent delivery system (sds) was advanced to the lesion; however no stent was seen on the delivery system.The stent was not seen on angiography.The physician could not recall if the stent was on the delivery system during prep.The device was removed and replaced.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported missing component (stent) was confirmed.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 missing component (stent) could not be determined.Missing components may be attributed to several factors including, but not limited to, manufacturing/packaging of the device, transport of the device, handling at the account, inadvertent mishandling during unpackaging, preparation or during the procedure.Return device analysis reported visible crimp marks where the stent was initially crimped on, suggesting that the stent was originally positioned correctly and securely at the time of manufacture.In this case, it is possible that the stent may have dislodged inside the protective sheath during sheath/stylet removal which resulted in the reported missing component (stent); however, a definitive cause for the reported missing component and observed dislodgement cannot be determined.It was reported that the 4.5x15mm herculink elite stent delivery system (sds) was advanced to the lesion; however, no stent was seen on the delivery system.The stent was not seen on angiography and the physician could not recall if the stent was on the delivery system during preparation of the device.It should be noted that per the rx herculink elite peripheral stent system instructions for use specifies: prior to using the rx herculink elite¿ peripheral stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent is located between the radiopaque balloon markers.Do not use if any defects are noted.It is unknown if the ifu deviation contributed to the reported event.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.G4:corrected pma/510(k) # from k053454 to p110001 h6: medical device problem code 2017- failure to follow steps / instructions.

• 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: 21931083
• Report Number: 2024168-2025-04469
• Device Sequence Number: 8715188
• Product Code: NIN
• UDI-Device Identifier: 08717648077920
• UDI-Public: (01)08717648077920(17)270331(10)4041261
• 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,Followup
• Report Date (Section B): 06/12/2025

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: 1011490-15
• Device Catalogue Number: 1011490-15
• Device Lot Number: 4041261
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• 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
• Patient Sex: Unknown