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

Model Number	1011487-15
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
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 a 4.0x15mm herculink elite balloon expandable stent system (bess) was prepared before the protective sheath was removed.The stent dislodged off the balloon prior to use.The bess was not used and there was no patient involvement.The procedure was successfully completed with a 4.5x12mm herculink stent.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned product.The reported stent dislodgment was confirmed.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 identified, no other complaints reported from this lot.It was reported, that herculink elite balloon expandable stent system (bess) was prepared, before the protective sheath was removed.It should be noted, that the rx herculink elite instructions for use (ifu) to remove the protective sheath, prior to flushing the guide wire lumen, and prior to the stent delivery system preparation.The investigation determined, that the reported stent dislodgment was use related.Based on the reported information, and evaluation of the returned unit, the stent dislodgment likely occurred, due to preparing the device prior to removing the protective sheath.It is likely, that pulling negative pressure to the balloon caused the stent to unseat from the balloon, resulting in dislodgement as the protective sheath was removed.There is no indication, of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Common Device Name: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11653974
• Report Number: 2024168-2021-03039
• Device Sequence Number: 11547919
• Product Code: NIN
• UDI-Device Identifier: 08717648077838
• UDI-Public: 08717648077838
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: 02/28/2023
• Device Model Number: 1011487-15
• Device Catalogue Number: 1011487-15
• Device Lot Number: 0031861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1