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

Catalog Number 1011534-18

Device Problem Break (1069)

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

Event Date 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat the left renal artery with moderate calcification and 70% stenosis.The 6x18 mm herculink elite stent delivery system (sds) was advanced and the stent was noted to be broken but remained in one piece.Therefore, the sds was simply removed immediately with the stent still on the balloon.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

Event Description

It was reported that the procedure was to treat the left renal artery with moderate calcification and 70% stenosis.The 6x18 mm herculink elite stent delivery system (sds) was advanced and the stent was noted to be broken but remained in one piece.Therefore, the sds was simply removed immediately with the stent still on the balloon.There were no adverse patient effects and there was no clinically significant delay in the procedure.A non-abbott sds was used to complete the procedure.Subsequent to the initially filed report, it was reported that the issue was a broken shaft, rather than a broken stent.No additional information was provided.

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported shaft break 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 incidents.The investigation determined the reported shaft break appears to be related to circumstances of the procedure, as it is likely that manipulation of the device during advancement including interaction with the moderately calcified, 70% stenosed lesion which contributed to the reported shaft break in addition to the observed bunched shaft and bunched inner member.Further manipulation of the device during retraction likely contributed to the observed stretched shaft and stretched inner member.There was no damage noted to the sds during the inspection prior to use or during preparation for use which suggests a product quality issue did not contribute to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 17781493
• MDR Text Key: 323841649
• Report Number: 2024168-2023-10313
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011534-18
• Device Lot Number: 3050861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2023
• 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