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

Model Number	1011496-12
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned to abbott vascular 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 similar incidents and/or complaints reported from this lot.The investigation was determined the reported failure to advance and stent dislodgement appear to be related to operational circumstances of the procedure.During advancement the device encountered resistance with the lesion causing the failure to advance.Manipulation against resistance likely resulted in the reported stent dislodgment during retraction.Additionally, the treatment appears to be related to the operational context of the procedure as the stent was removed using a snare device.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that this was a procedure to treat a lesion with heavy calcification in the left renal artery.The lesion was pre-dilated successfully.A 5.5 x 12 mm herculink stent delivery system (sds) was advanced but could not cross the heavily calcified lesion and during the attempt the stent dislodged.The dislodged stent remained on the guide wire.The sds was removed without issue.A snare device was used to help retrieve the dislodged stent.A new herculink sds was used to complete the procedure.No additional information was provided.

• 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: 12313355
• Report Number: 2024168-2021-07101
• Device Sequence Number: 4412089
• Product Code: NIN
• UDI-Device Identifier: 08717648078095
• UDI-Public: 08717648078095
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 08/12/2021

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: 12/31/2023
• Device Model Number: 1011496-12
• Device Catalogue Number: 1011496-12
• Device Lot Number: 1011861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/12/2021
• 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: 79 YR