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

Model Number	1011493-12
Medical Device Problem Codes	Difficult to Remove (1528); Migration (4003)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the renal artery.The 5x12mm herculink elite balloon expandable stent (bes) was deployed; however, when the delivery system was being removed, the balloon became stuck in the stent and the stent migrated from the target lesion.There were no reported adverse patient effects and there was 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.
Event or Problem Description
Subsequent to the initially filed report, the account stated that the lesion treated have heavy calcification and heavy tortuosity.The stent was deployed and placed in the target lesion; however, was moved partially outside the target lesion during removing the delivery system.The viatrac balloon was used to position the herculink stent back to the target lesion again.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the subsequent unexpected medical intervention appears to be related to the operational context of the procedure.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.H6- health effect - clinical code 2687 was removed and replaced with code 4582; health effect - impact code 4614 was removed and replaced with code 4641.

• 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: 16686601
• Report Number: 2024168-2023-03547
• Device Sequence Number: 5921383
• Product Code: NIN
• UDI-Device Identifier: 08717648078002
• UDI-Public: 08717648078002
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 1011493-12
• Device Catalogue Number: 1011493-12
• Device Lot Number: 1052061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown