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

Model Number	1011493-12
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat the renal artery that is 80% stenosed.The 5.0x12mm herculink elite stent delivery system (sds) was advanced to the target lesion.Resistance was noted during advancement; however, it is unknown what the device met resistance with.The stent was observed to have moved on the balloon in the sheath and failed to cross the lesion.The sds was removed with the stent still on the sds and a new 5.0x12mm herculink elite was used to complete the procedure.There was no adverse patient effects and no 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 stent dislodgement was confirmed.The reported failure to advance and difficult to advance/position could not be evaluated as the exact accessory devices and anatomical conditions encountered by the device used during the procedure could not be replicated in the test laboratory.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 identified no similar incidents from this lot.A conclusive cause for the reported difficulties could not be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
Subsequently, after the initial was filed it was noted that an attempt was made to inflate the balloon to secure the stent after it was observed moved; however the stent was in the sheath.No additional information was provided.

• 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: 16506432
• Report Number: 2024168-2023-02401
• Device Sequence Number: 14275475
• Product Code: NIN
• UDI-Device Identifier: 08717648078002
• UDI-Public: 08717648078002
• 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): 05/22/2023

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: 01/31/2025
• Device Model Number: 1011493-12
• Device Catalogue Number: 1011493-12
• Device Lot Number: 2021861
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2022
• 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
• Patient Sex: Unknown