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

Model Number	1011487-18
Medical Device Problem Codes	Off-Label Use (1494); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that the procedure was to treat the mildly calcified, mildly tortuous left vertebral artery.The 4.0x18 mm herculink elite stent delivery system was advanced to the lesion and upon inflation of the balloon, it was found that the balloon would not inflate at all to deploy the stent.Therefore, the device was removed and another same size herculink elite stent was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device and the reported stent deployment issue was unable to be confirmed as the balloon inflated deploying the stent without any issues noted.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 similar incidents and/or complaints reported from this lot.It should be noted the rx herculink elite renal and biliary stent system instructions for use, indication for use (ifu) section 3.0 states: the rx herculink elite renal stent system is indicated for use in patients with atherosclerotic disease of the renal arteries following sub-optimal percutaneous transluminal renal angioplasty (ptra) of a de novo or restenotic atherosclerotic lesion(= 15 mm in length) located within 10 mm of the renal ostium and with a reference vessel diameter of 4.0 ¿ 7.0 mm.Suboptimal ptra is defined as = 50% residual stenosis, = 20 mmhg peak systolic or = 10 mmhg mean translesional pressure gradient, flow -limiting dissection, or timi [thrombolysis in myocardial infarction] flow < 3.In this case, the ifu violation of used in the wrong anatomy did not cause or contribute to the reported complaint.Factors that may contribute to stent deployment issues may include, but are not limited to, manufacturing, bent/kinked shaft while inside the anatomy, contamination in the inflation lumen preventing deployment, patient anatomical morphology, patient disease state, inflation technique, contrast solution, inadequate connection to the inflation device, and/or accessory devices used.The investigation was unable to determine a conclusive cause for the reported activation/deployment failure.It was reported that the balloon would not inflate at all to deploy the stent.It is possible that the accessory devices used in the procedure were closed preventing the contrast flow into the balloon resulting in the stent deployment issue; however, this could not be confirmed.The noted damages on the stent, balloon and outer/inner member likely occurred during packing for return analysis and there were no damages reported on the device.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 11939704
• Report Number: 2024168-2021-04668
• Device Sequence Number: 4176195
• Product Code: NIN
• UDI-Device Identifier: 08717648077845
• UDI-Public: 08717648077845
• 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): 08/03/2021

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: 05/31/2022
• Device Model Number: 1011487-18
• Device Catalogue Number: 1011487-18
• Device Lot Number: 9061061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1