MAUDE Adverse Event Report: ABBOTT VASCULAR RX HERCULINK ELITE STENT SYSTEM; STENT, RENAL

Catalog Number	1011493-15
Medical Device Problem Codes	Off-Label Use (1494); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a right vertebral artery.The 5.0x15mm herculink elite balloon expandable stent was attempted to be deployed; however, the balloon would not expand after pressure was applied resulting in the stent failing to deploy.A new 5x12mm herculink stent was used to successfully complete the procedure.There was no adverse patient effects and clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code 1494 clarifier- incorrect anatomy.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported activation failure was not confirmed.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no similar complaints from this lot.It was reported that the procedure was to treat a right vertebral artery.It should be noted that per the rx herculink elite peripheral stent system instructions for use (ifu) specifies: the rx herculink elite¿ peripheral stent system is indicated for improving arterial luminal diameter in patients with atherosclerotic lesions in renal arteries.It is unknown the ifu deviation contributed to the reported event.A conclusive cause for the reported activation failure including expansion failures could not be determined; however, factors that may contribute to activation failures including expansion failures include, but are not limited to, inflation technique, contrast concentration, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.Based on the information provided and analysis of the returned device, a definitive cause for the reported activation failure including expansion failures cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Common Device Name: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 19215586
• Report Number: 2024168-2024-05271
• Device Sequence Number: 18169164
• Product Code: NIN
• UDI-Device Identifier: 08717648078019
• UDI-Public: (01)08717648078019(17)260228(10)3031461
• 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): 06/19/2024

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: 02/28/2026
• Device Catalogue Number: 1011493-15
• Device Lot Number: 3031461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/07/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• 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