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

Model Number 1011505-15

Device Problems Break (1069); Leak/Splash (1354); Difficult or Delayed Activation (2577)

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

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was performed to treat a 90% stenosed and mildly calcified lesion in the superior mesenteric artery.The 7.0x15mm herculink elite balloon-expandable stent system was prepared prior to use without issues.During deployment of the stent it was noted that the hub was broken/cracked and a leak was noted which didn¿t allow for full deployment of the stent.The stent was able to be deployed; however, post-dilatation was required to fully deploy the stent.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and functional analysis was performed on the returned product.The reported broken nose piece and leak was confirmed.The deployment difficulty was not confirmed as the stent had already been deployed and was not returned.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 complaints.The investigation was unable to determine a cause for the reported broken nose piece resulting in leak, deployment difficulty and unexpected medical intervention.It was reported that device was prepared prior to use without issues, indicating that the damage was not pre-existing.It may be possible that the hub was inadvertently mishandled during insertion into the introducer sheath or guide catheter causing the nose piece to crack; 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: 12125256
• MDR Text Key: 260262871
• Report Number: 2024168-2021-05751
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648078378
• UDI-Public: 08717648078378
• 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: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 1011505-15
• Device Catalogue Number: 1011505-15
• Device Lot Number: 8111261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 50