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

Catalog Number UNK HERCULINK ELITE

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

Patient Problems Intimal Dissection (1333); Occlusion (1984)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Dates of event and implant: estimated dates.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed because the part and lot numbers were not reported.The reported patient effects of dissection and occlusion are listed in the herculink elite instruction for use as known potential patients effects associated with the use of a stent in peripheral arteries and / or biliary tree.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The additional therapy/non-surgical treatment surgical procedure, and hospitalization were likely related to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.Article titled: ¿herculink elite post market clinical follow-up report." the additional adverse patient effect of death referenced is being filed under a separate medwatch report#.

Event Description

It was reported through a research article identifying herculink elite stents that may be related to the following: death, target lesion dissection, unplanned amputation, occlusion, intervention re-treatment, and surgical re-treatment.Details are listed in the article, titled ¿herculink elite post market clinical follow-up report.".

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10590830
• MDR Text Key: 208722181
• Report Number: 2024168-2020-08037
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HERCULINK ELITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability