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

Model Number	1011487-15
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for investigation.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 a mildly calcified left vertebral artery that is 90% stenosed.The physician decided to use a 4.0x15mm herculink elite balloon expandable stent as it matched the size of the lesion.The herculink was advanced and after the balloon was inflated no stent was found under angiography.The stent delivery system was withdrawn and the stent was found in the protective sheath.A new 4.5x12mm herculink was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device which identified the outer member was separated from the balloon proximal seal, but the balloon remained over the inner member.The inner member was separated distal to the distal balloon marker band and was not returned.The tip was separated and was not returned.Additional follow up with the account confirmed the separations occurred due to handling and packaging after the procedure.The stylet was noted bent distal to the proximal end, which likely occurred as a result of handling/packaging of the device for return to abbott vascular for analysis.The reported stent dislodgement was confirmed.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 other incidents.It was reported that the procedure was to treat a mildly calcified left vertebral artery that is 90% stenosed.It should be noted that the rx herculink elite peripheral stent system instructions for use (ifu) specifies: the rx herculink elite¿ peripheral stent system is indicated to open lumen restrictions in the biliary tree, renal arteries, and protected peripheral arteries.It is unknown if the ifu deviation contributed to the reported event.In addition, it was reported that the stent implant was not on the balloon after the device had been advanced into the anatomy.It should be noted that 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.In this case, it is unknown the ifu deviation contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported stent dislodgement.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: 12720308
• Report Number: 2024168-2021-09723
• Device Sequence Number: 11760078
• Product Code: NIN
• UDI-Device Identifier: 08717648077838
• UDI-Public: 08717648077838
• 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): 01/14/2022

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: 12/31/2023
• Device Model Number: 1011487-15
• Device Catalogue Number: 1011487-15
• Device Lot Number: 1011861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2021
• 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
• Patient Sex: Unknown