MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HERCULINK ELITE; STENT, RENAL

Model Number	1011490-12
Medical Device Problem Codes	Off-Label Use (1494); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon preparation of the herculink elite stent delivery system (sds), the stent dislodged from the delivery system when the protective sheath was removed and the stent remained in the sheath.There was no device use or patient involvement.Another herculink elite sds was used to complete the procedure.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 it was reported that the device was advanced to the lesion at the vertebral artery and inflated and then it was noted the stent had dislodged in the protective sheath as it was not on the delivery system.There were 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 dislodgment was confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on observations from the returned analysis, it may be possible that the stent and tip of the catheter was inadvertently grasped tight with the protective sheath during removal causing the stent to dislodge from the balloon and the noted damage to the tip and protective sheath.However, this could not be confirmed.It was reported that the procedure was performed to treat a vertebral artery.It should be noted that the rx herculink elite peripheral stent system instructions for use (indications for use) specifies: the rx herculink elite¿ peripheral stent system is indicated for improving arterial luminal diameter in patients with atherosclerotic lesions in renal arteries.It is unknown if the ifu deviation directly caused or contributed to the reported event.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.B5: describe event or problem updated b6: relevant test/laboratory data updated b7: other relevant history updated h6: health effect - impact code 2645 removed, 2199 added.

• Brand Name: HERCULINK ELITE
• Common Device Name: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20964694
• Report Number: 2024168-2024-14941
• Device Sequence Number: 3955011
• Product Code: NIN
• UDI-Device Identifier: 08717648077913
• UDI-Public: (01)08717648077913(17)251130(10)2120961
• 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): 01/23/2025

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: 11/30/2025
• Device Model Number: 1011490-12
• Device Catalogue Number: 1011490-12
• Device Lot Number: 2120961
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2022
• 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