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

Model Number	1011505-15
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem 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.
Additional 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
• Common Device Name: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12125256
• Report Number: 2024168-2021-05751
• Device Sequence Number: 3592654
• Product Code: NIN
• UDI-Device Identifier: 08717648078378
• UDI-Public: 08717648078378
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 50