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

Model Number 1011496-12

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/23/2021

Event Type  Injury  

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 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
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12313355
• MDR Text Key: 266218282
• Report Number: 2024168-2021-07101
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648078095
• UDI-Public: 08717648078095
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR