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

Model Number 1011505-18

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

The device was returned.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that this was a procedure to treat a left external iliac artery.A herculink elite 7/18mm stent was inserted and deployed without issues.However, after deployment, a fragment of the balloon delivery catheter was noted in the anatomy.Therefore, a snare was inserted, and the fragmentation was successfully removed.The patient was noted to be in stable condition and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A visual inspection was performed on the returned device and the reported separation 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 similar incidents and/or complaints reported from this lot.The device was prepped prior to use without any leak or ruptures noted, which would suggest that the device was not damaged prior to use.Although there was limited information provided by the account, based on the returned analysis and the scanning electron microscopy (sem) report, the investigation determined the reported separation and noted damages appear to be related to operational circumstances of the procedure.It is likely that the balloon ruptured prior to separation.The balloon likely did not refold as intended due to the rupture resulting in resistance during retraction.Manipulation against resistance caused the tearing on the balloon and stretching/necking and jagged edges to the inner member ultimately resulting in the separation.Additionally, the treatment appears to be related to the operational context of the procedure a snare was inserted, and the fragmentation was successfully removed.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 11402346
• MDR Text Key: 234407358
• Report Number: 2024168-2021-01536
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648078385
• UDI-Public: 08717648078385
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 1011505-18
• Device Catalogue Number: 1011505-18
• Device Lot Number: 0081161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 107