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

Model Number	1011487-12
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	04/17/2024
Type of Reportable Event	Malfunction
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 was to treat the renal artery with 80% stenosis.The 4.0x12mm herculink elite stent delivery system (sds) was attempted to be advanced and the stent dislodged inside the catheter before it reached the lesion.The sds was withdrawn with the stent attached and another herculink sds was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported failure to advance could not be tested as the accessory devices used in procedure were not returned.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database did not indicate a lot of specific quality issue.A conclusive cause for the reported difficulties could not be determined; however, factors that could contribute to failure to advance include, but are not limited to, patient anatomical morphology, patient disease state, pre-dilatation strategy, device placement technique, interaction with previously placed stents or accessory devices.Stent dislodgement may be attributed to several factors including, but not limited to, improper or inadequate crimping at the time of manufacture, incorrect sheath sizing, positive pressure during preparation, forced sheath removal, handling of the stent during preparation, interaction with the anatomy, or interaction with accessory devices.Based on the information provided and analysis of the returned device, a definitive cause for the reported failure to advance and stent dislodgement cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.Corrections: d1 ¿ brand name: updated d3 ¿ name, address 1, city, postal code: updated.

• 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: 19270247
• Report Number: 2024168-2024-05642
• Device Sequence Number: 12608435
• Product Code: NIN
• UDI-Device Identifier: 08717648077821
• UDI-Public: (01)08717648077821(17)260228(10)3030961
• 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): 07/08/2024

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: 02/28/2026
• Device Model Number: 1011487-12
• Device Catalogue Number: 1011487-12
• Device Lot Number: 3030961
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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