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

Catalog Number	1011487-15
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the left renal artery with severe calcification and 90% stenosis.The lesion was pre-dilated with a 3.0x15 mm balloon and then a 4.0x15 mm balloon.A 6fr guiding catheter was attempted but could not cross the lesion.Then the 4.0x15 mm herculink elite stent delivery system (sds) was advanced over an.014 guide wire across the lesion and the stent dislodged from the delivery system.The stent remained on the wire but came off of the balloon.The delivery system was removed and a smaller balloon was used to pull the stent out of the patient.A 4.0 balloon was used to dilate the lesion again and a guiding catheter was advanced.A new 4.0x18 mm sds was used to complete the procedure.There were no reported adverse patient sequela and there was no reported clinically significant delay in the procedure.
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 was performed on the returned device.The reported stent dislodgement was confirmed.The reported difficult to advance/position could not be evaluated as the exact anatomical conditions encountered by the device used during the procedure could not be replicated in the test laboratory in addition to the condition of the returned device.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.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the subsequent unexpected medical intervention (additional therapy/non-surgical treatment) appears to be related to circumstances of the procedure.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: 18521690
• Report Number: 2024168-2024-00890
• Device Sequence Number: 7773299
• Product Code: NIN
• UDI-Device Identifier: 08717648077838
• UDI-Public: 08717648077838
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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: 12/31/2024
• Device Catalogue Number: 1011487-15
• Device Lot Number: 2010761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2022
• 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: .014 GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 70 KG