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

Model Number	1011499-18
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6 - medical device problem code 2017 clarifier - use after damage.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 performed to treat a lesion with mild calcification and tortuosity in the renal artery with a 6.0x18mm 135cm rx herculink elite balloon expanding stent (bes).Reportedly during device preparation, the tip of the catheter was noted to have fallen off when the guide wire lumen was flushed; however, the device was still used to complete the procedure.There was 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 material separation (tip) was confirmed.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 identified no other complaints.It was reported that during device preparation, the tip of the catheter was noted to have fallen off when the guide wire lumen was flushed; however, the device was still used to complete the procedure.It should be noted that per the rx herculink elite peripheral stent system instructions for use (stent inspection prior to use) specifies: prior to using the rx herculink elite¿ peripheral stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent is located between the radiopaque balloon markers.Do not use if any defects are noted.It is unknown if the ifu deviation directly caused or contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported material separation (tip).Factors contributing to a material separation include, but are not limited to, damage during manufacturing, interaction with accessory devices or inadvertent mishandling.In this case, it is possible that the reported material separation (tip) and observed bunched tip may have occurred due to inadvertent mishandling during sheath/stylet removal or during preparation of the device, however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6 correction: health effect - impact code 4648 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: 19629442
• Report Number: 2024168-2024-07765
• Device Sequence Number: 12549329
• Product Code: NIN
• UDI-Device Identifier: 08717648078200
• UDI-Public: (01)08717648078200(17)261031(10)3110761
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/06/2024

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 Model Number: 1011499-18
• Device Catalogue Number: 1011499-18
• Device Lot Number: 3110761
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• 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