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

Model Number	1011490-15
Medical Device Problem Codes	Off-Label Use (1494); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a heavily tortuous right vertebral artery.The physician chose a 4.5x15mm herculink elite balloon-expandable stent system (bess) as there was no other product option available that was the appropriate size for treatment based on the diameter and length of the vessel.The bess was advanced over the guide wire into the patient; however, the stent dislodged.Currently, the stent remains embedded in an unspecified vessel with no further treatment provided.There was no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 incidents.A cine was received and reviewed by an abbott vascular clinical specialist.Per the report, treatment was for a heavily calcified right vertebral artery.The physician chose a 4.5mm x 15mm herculink elite balloon expandable stent system (bess) as there was no other product option available that was the appropriate size for treatment based on the vessel.This took place in a remote city which could explain the limited inventory of bess.Regardless of location, the use of the herculink elite bess is off label.The rx herculink elite¿ peripheral stent system is indicated to open lumen restrictions in the biliary tree, renal arteries, and protected peripheral arteries.Vertebral arteries are not considered peripheral.There was no malfunction with the device but, that the device was selected for use in an anatomical location that it was not indicated for.It was reported that the procedure was to treat a heavily tortuous right vertebral artery.It should be noted the rx herculink elite peripheral stent system instructions for use (ifu) specifies: the rx herculink elite¿ peripheral stent system is indicated to open lumen restrictions in the biliary tree, renal arteries, and protected peripheral arteries.It is possible the ifu deviation contributed to the reported event.The investigation determined the reported stent dislodgement appears to be related to circumstances of the procedure.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.

• 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: 12365173
• Report Number: 2024168-2021-07509
• Device Sequence Number: 4536012
• Product Code: NIN
• UDI-Device Identifier: 08717648077920
• UDI-Public: 08717648077920
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 1011490-15
• Device Catalogue Number: 1011490-15
• Device Lot Number: 1041361
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR