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

Model Number	1011505-18
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Activation Failure (3270)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.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 tight lesion located in the right common iliac artery, that was not predilated.The rx herculink stent system was advanced, possibly with resistance through the 6f radial sheath to the lesion and during deployment, resistance was noted and the stent dislodged.The stent was crushed against the vessel wall and an omnilink stent was implanted to cover the crushed stent.There was no adverse patient sequela or a clinically significant delay in procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned product.The reported difficulty advancing, and deployment issue were not tested as the stent was not on the balloon and not returned.The stent dislodgment was confirmed.It was noted that the balloon was tightly folded and there were crimp marks visible on the balloon between the balloon markers.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.The investigation determined that the reported difficulties and subsequent treatment to embed the dislodged stent to the vessel wall were due to case circumstances.It is likely that the resistance encountered during advancement was due to interaction with the introducer sheath.The lesion was described as tight which may have compromised the inner diameter of the introducer sheath contributing to the resistance.Additionally, the difficulty deploying the stent and dislodgment was likely the result of the distal end of the herculink elite being bent or entrapped in the tight lesion preventing adequate inflation to the balloon to fully expand the stent resulting in dislodgment.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: 11402546
• Report Number: 2024168-2021-01654
• Device Sequence Number: 11633848
• Product Code: NIN
• UDI-Device Identifier: 08717648078385
• UDI-Public: 08717648078385
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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: 11/30/2023
• Device Model Number: 1011505-18
• Device Catalogue Number: 1011505-18
• Device Lot Number: 0121061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 04/08/2021
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 70