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

Model Number 1011499-12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Pain (1994); Perforation (2001)

Event Date 09/01/2010

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated.Date of implant: estimated.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the lot number was not reported.The reported patient effects of dissection, perforation and pain are listed in the rx herculink elite instructions for use as known patient effects associated with the use of the device.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Article title: covered stents in renal artery interventions.

Event Description

It was reported through a research article that a herculink stent was implanted in the calcified right renal artery without issue; however, a dissection was noted.No treatment was provided.While observing the patient post procedure, the patient complained of abdominal pain and angiography noted free flow of contrast.A 5.5x15mm balloon was inflated to tamponade the bleed.There was no reported adverse patient sequela.Details are listed in the article, titled ¿covered stents in renal artery interventions¿.

Manufacturer Narrative

This report is resubmitted to ensure the enclosed attachment can be easily opened by the fda.Article attached: ¿covered stents in renal artery interventions.¿.

• 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: 10286900
• MDR Text Key: 199244853
• Report Number: 2024168-2020-05918
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648078187
• UDI-Public: 08717648078187
• Combination Product (y/n): N
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1011499-12
• Device Catalogue Number: 1011499-12
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR