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

Model Number	1011499-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intimal Dissection (1333); Pain (1994); Perforation (2001)
Date of Event	09/01/2010
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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¿.
Additional 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
• Common Device Name: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10286900
• Report Number: 2024168-2020-05918
• Device Sequence Number: 2679646
• Product Code: NIN
• UDI-Device Identifier: 08717648078187
• UDI-Public: 08717648078187
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1011499-12
• Device Catalogue Number: 1011499-12
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 07/30/2020
• 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: 82 YR