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

Model Number 1011487-12

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/28/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a moderately calcified right renal artery that is 90% stenosed.The 4.0x12mm herculink balloon expandable stent system (bess) was attempted to be advanced; however, failed to cross due to anatomy.The bess was removed and an unspecified 2.0x15mm coronary balloon was used to dilate the lesion.The same bess was re-inserted but failed to cross due to anatomy.During removal, due to the angle of the unspecified guide catheter the bess met resistance with it and the stent dislodged.Several attempts were made to retrieve the floating stent by inserting an unspecified balloon in the stent and partially deploy it in an attempt to snare the stent with the balloon; however, the stent got caught with an unspecified wire and the tip of the unspecified wire separated.Both the tip of the wire and the stent were free floating in the right common femoral artery.The patient was put under anesthesia and a cut down was performed.The stent and tip of the unknown wire were successfully removed, and the patient is doing well.Additionally, the event did cause the patient's hospitalization to be prolonged and a clinically significant delay was noted.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.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.Based on the information provided, the reported difficulties resulting in surgical procedure to remove the separated portion of guide wire and the dislodged stent appear to be due to circumstances of the procedure.The difficulty encountered during advancement was due to interaction with the challenging anatomy.Additionally, it was reported that after the first failed attempt to advance, the balloon expandable stent system (bess) was removed for additional dilation of the lesion, then re-advanced in which the bess failed to cross for a second time.It is likely that during the second failed attempt to cross the lesion, the stent became compromised or loose on the balloon resulting in dislodgement during removal when the stent interacted with the guide catheter.The delay in the procedure and prolonged hospitalization were due to case circumstances.It should be noted that the herculink elite instruction for use states: ¿do not attempt to pull an unexpanded stent back through the introducer sheath / guiding catheter; dislodgment of the stent from the balloon may occur.¿ in this case, it could not be determined if re-insertion of the herculink caused or contributed to the stent dislodgement.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
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12320184
• MDR Text Key: 266564765
• Report Number: 2024168-2021-07148
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648077821
• UDI-Public: 08717648077821
• Combination Product (y/n): N
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 1011487-12
• Device Catalogue Number: 1011487-12
• Device Lot Number: 0031861
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 90 YR
• Patient Weight: 63