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

Catalog Number 1011534-12

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

Patient Problems Nausea (1970); Pain (1994); Thrombosis (2100)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product 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.The reported patient effect of pain and thrombosis are listed in electronic instructions for use, peripheral stent system rx herculink elite, ce as known patient effects of coronary stenting procedures a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.Additionally, treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The other herculink stent referenced is filed under separate medwatch report number.

Event Description

It was reported that the procedure was to treat stenosis in the left renal artery and in-stent restenosis at the right renal artery.A 6.0x12mm herculink elite stent was successfully implanted at the left artery and another same size herculink was implanted at the right artery.Later that afternoon, the patient experienced abdominal pain with nausea and vomiting.A cat scan was performed and noted thrombosis in both renal arteries.Heparin was administered.The next morning ultrasound was performed.The right renal artery was fully opened; however, the status of the left renal artery could not be interpreted.Additionally, a hematoma was noted at the left femoral puncture site with active bleeding.The patient was taken to surgery where the artery was sutured, and the patient received a blood transfusion.The patient recovered and was walking in the unit.No additional information was provided.

• 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: 10645293
• MDR Text Key: 210417840
• Report Number: 2024168-2020-08357
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 1011534-12
• Device Lot Number: 9120761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2019
• 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