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

Catalog Number	1011487-15
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
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
It was reported that the procedure on (b)(6) 2023 was to treat a 70% stenosed lesion in the left vertebral artery ostium.A guide wire was placed and pre-dilatation was performed.The 4.0x15mm herculink elite stent delivery system (sds) was attempted to be advanced to the target lesion; however, failed to advance due to the anatomy.When the sds was being removed to perform additional pre-dilatation, the stent dislodged at the ostium of the vertebral artery.The herculink sds was removed and a 1.5x15mm balloon was used to attempt to remove the stent.The stent was retracted back to the femoral artery, but was not able to be removed with the balloon.The patient had no discomfort and blood flow was smooth.The patient was placed temporarily on anti-platelet medication and monitored.Then, on 10/03/2023 digital subtraction angiography (dsa) was performed and a surgical incision was made to remove the stent.The patient is in good condition.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties and subsequent surgical intervention, unexpected medical intervention (additional therapy/non-surgical treatment), and medication required appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.

• 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: 18132327
• Report Number: 2024168-2023-12619
• Device Sequence Number: 20771593
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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: 03/31/2025
• Device Catalogue Number: 1011487-15
• Device Lot Number: 2041161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown