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

Model Number	1011487-12
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that during device preparation of a 4x12mm herculink elite renal balloon expandable stent system (bess), force was applied with the removal of the protective covering and the stent moved on the balloon, exposing the proximal balloon and rendering the device unusable.There was no patient involvement and no clinically significant delay in the procedure.Another same size herculink was prepared and used to successfully complete the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initial filed emdr report, the following information was received: it was reported that during device preparation of a 4x12mm herculink elite renal balloon expandable stent system (bess), force was applied with the removal of the protective covering and the stent moved on the balloon, exposing the proximal balloon.The device was advanced over the guide wire and into the sheath when the inner member was noticed as stretched and bunched.There was no adverse patient effect and no clinically significant delay in the procedure.Another same size herculink was prepared and used to successfully complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned product.The reported stent movement and damage to the inner member was confirmed.Additionally, it was noted that the delivery system was stuck on the guide wire.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no indication of a lot specific product quality issue.It should be noted that the rx herculink elite instructions for use (ifu) states: special care must be taken not to handle or in any way disrupt the stent on the balloon.This is most important during stent system removal from the packaging, placement over a guide wire, and advancement through a guiding catheter or introducer sheath.Additionally, prior to using the rx herculink elite peripheral stent system, carefully remove the system from the packaging 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.In this case, it could not be determined if the ifu deviations caused or contributed to the difficulties encountered.The investigation was unable to determine a cause for the reported difficulties.Based on the reported information, the stent movement likely occurred during forceful removal of the protective sheath.It may be possible that the protective sheath was inadvertently grasped too tight during removal causing damage to the proximal seal and the inner member to become stretched resulting in the noted device stuck on the guide wire; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: health effect impact code 2645 removed.

• 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: 13178914
• Report Number: 2024168-2022-00190
• Device Sequence Number: 4486011
• Product Code: NIN
• UDI-Device Identifier: 08717648077821
• UDI-Public: 08717648077821
• 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): 02/28/2022

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: 02/29/2024
• Device Model Number: 1011487-12
• Device Catalogue Number: 1011487-12
• Device Lot Number: 1031161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2021
• 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