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

Model Number	1011487-12
Medical Device Problem Codes	Difficult to Advance (2920); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left renal artery with 85% stenosis.After the vessel was prepped, the 4.0x12mm herculink elite stent delivery system (sds) was advanced with resistance felt from an unspecified guiding catheter.An attempt was made to deploy the stent; however, it would only partially deploy.T he sds and stent were withdrawn, and a new 4.0x12mm herculink stent was implanted, with angiography confirming patency.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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
A visual inspection, functional testing, dimensional analysis was performed on the returned device.The reported activation failure was not confirmed.The reported difficult to advance could not be tested as it was based on operational context.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.The investigation was unable to determine a conclusive cause for the reported difficulties.It was reported that the balloon expanding stent (bes) encountered resistance with a guiding catheter during advancement.Factors that may contribute to difficulty advancing the bes through the guide catheter include, but are not limited to, inner diameter of the catheter, outer diameter of the bes, device support, buildup of procedural contaminants, user technique, and/or damage to the catheter or bes.Analysis of the bes confirmed that the crossing profile met specification.Based on the information provided and the results of the returned device analysis, it is unknown what may have caused the reported difficulty during advancement.Additionally, it was reported that the stent failed to activate once it reached the lesion.Functional analysis was performed on the bes, inflating it to rated burst pressure (rbp).The balloon was able to successfully inflate and expand the stent.It is possible that circumstances of the procedure, such as inflation technique, contributed to the reported activation failure.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• 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: 20839003
• Report Number: 2024168-2024-14232
• Device Sequence Number: 18152479
• Product Code: NIN
• UDI-Device Identifier: 08717648077821
• UDI-Public: (01)08717648077821(17)251031(10)2111061
• 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): 01/23/2025

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: 10/31/2025
• Device Model Number: 1011487-12
• Device Catalogue Number: 1011487-12
• Device Lot Number: 2111061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• 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: UNSPECIFIED GUIDING CATHETER
• Patient Sex: Unknown