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

Model Number 1011493-18

Device Problems Break (1069); Leak/Splash (1354); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the procedure was to treat an 80% stenosed lesion in the right renal artery.Pre-dilatation was performed with a non-abbott 4.0x20mm balloon dilatation catheter at 12 atmospheres.The 5.0x18mm herculink stent delivery system (sds), was advanced to the lesion and was inflated to 10 atmospheres, delivering the stent to the lesion; however, a leak was noted coming from the hub.The sds was removed and the hub was observed to be cracked and then the hub broke off.The herculink stent was post dilated with a non-abbott balloon at 14 atmospheres.The patient was fine.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned product.The reported broken nose piece was confirmed.The leak was not confirmed as no further testing was performed due to the separation.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.Based on the reported information and analysis of the returned unit, a definitive cause for the broken nose piece resulting in leak could not be determined.It may be possible that the hub was inadvertently damaged during removal from the dispenser coil causing the nose piece to crack and with additional handling during use, the device leaked from the crack and ultimately separated with additional handling; however, this could not be confirmed.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: 10610696
• MDR Text Key: 209366110
• Report Number: 2024168-2020-08158
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648078026
• UDI-Public: 08717648078026
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 1011493-18
• Device Catalogue Number: 1011493-18
• Device Lot Number: 8120462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR