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

Model Number	1011490-18
Medical Device Problem Codes	Off-Label Use (1494); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/28/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the left vertebral artery that was heavily calcified, mildly tortuous and 80% stenosed.The rx herculink elite stent system was advanced to the lesion, but the stent was not there and was not able to be found in the patient.The device was removed without issue.The patient did not experience any adverse sequela.Another stent of the same type was accurately positioned and deployed to complete 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.It was reported that the herculink elite was being used to treat the left vertebral artery.It should be noted that the herculink elite instruction for use (ifu) states: the rx herculink elite peripheral stent system is intended to open lumen restrictions in the biliary tree, renal arteries, and protected peripheral arteries.In this case, it could not be determined if the off-label use caused or contributed or the reported difficulties.The investigation was unable to determine a cause for the reported difficulty.It may be possible that the guide catheter was bent or collapsed in the anatomy causing reduced clearance for the omnilink elite resulting in stent dislodgment within the sheath; 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.

• 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: 11183335
• Report Number: 2024168-2021-00508
• Device Sequence Number: 11788167
• Product Code: NIN
• UDI-Device Identifier: 08717648077937
• UDI-Public: 08717648077937
• 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): 03/08/2021

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: 02/28/2022
• Device Model Number: 1011490-18
• Device Catalogue Number: 1011490-18
• Device Lot Number: 9032261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 01/17/2021
• Supplement Report FDA Received Date: 03/08/2021
• 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