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 Problem Stenosis (2263)

Event Date 09/19/2021

Event Type  Injury  

Event Description

It was reported that a 44-year-old male patient presented with a history of postprandial abdominal angina.A ct angiogram revealed a 90% stenosed celiac artery followed by a total occlusion at the hepatic artery.A 7.00x18mm herculink elite stent was implanted and flow was re-established.Three years later, the patient presented with recurrence of symptoms and total occlusion of the implanted 7.00x18mm herculink elite stent was noted.Standard medications were administered.A 0.014 hi-torque whisper guidewire (gw) was advanced, but the guide catheter support was not adequate and the wire failed to reach its desired location, so the wire was removed and exchanged with a non-abbott gw.Pre-dilatation was performed followed by stent implantation and post-dilatation.A final angiogram confirmed good flow reestablished in the arteries.The patient was discharged the following day on standard medication.1 year post re-intervention, the patient remains symptom free.Please see attached article titled percutaneous endovascular recanalization of celiac artery in-stent occlusion ¿ a case report for additional information.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Dates estimated: the udi number is not known as the part and lot number were not provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.The reported patient effect of stenosis is listed in the rx herculink elite peripheral stent system instructions for use as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 16709555
• MDR Text Key: 312981109
• Report Number: 2024168-2023-03660
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• 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: 04/13/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 44 YR
• Patient Sex: Male