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

Model Number	1011487-15
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a heavily tortuous, mildly calcified right renal artery.A non-abbott stent 3.0x15mm would not cross and attempted 3 times.The 4.0x15mm herculink stent was selected; however, failed to cross due to anatomy.During removal, resistance was felt with anatomy and the stent dislodged.The physician was able to snare the stent to the common femoral artery; however, could not remove it.Therefore, cut down was performed and the stent was removed.No other device was used as no device was able to cross.There was no adverse patient sequela and 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.
Additional Manufacturer Narrative
The device was not returned for analysis.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 the reported information, it is likely that the failure to cross was due to interaction with the challenging anatomy.Additionally, it is likely that during the attempt to advance against resistance, the stent to become compromised on the balloon resulting in difficulty removing and dislodgment.As a result, unexpected medical intervention in the attempt to snare the dislodged stent was unsuccessful; therefore, surgical intervention via cut down was required to remove the stent.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9 correction: device available for evaluation updated from returning to not returning.

• 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: 20090652
• Report Number: 2024168-2024-10211
• Device Sequence Number: 20732806
• Product Code: NIN
• UDI-Device Identifier: 08717648077838
• UDI-Public: (01)08717648077838(17)250131(10)2021561
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 01/15/2025

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: 01/31/2025
• Device Model Number: 1011487-15
• Device Catalogue Number: 1011487-15
• Device Lot Number: 2021561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2022
• 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: Required Intervention
• Patient Sex: Unknown