MAUDE Adverse Event Report: EV3, INC. EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number EVD35-07-060-150

Device Problems Premature Activation (1484); Off-Label Use (1494)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2020

Event Type  malfunction  

Event Description

Premature deployment of intravascular stent.A 7 mm x 60 mm everflex stent was being used to treat dural sinus stenosis causing symptomatic idiopathic intracranial hypertension (pseudotumor cerebri) in a symptomatic (b)(6) woman.This was off label use, as there is no stent currently approved for this purpose.The stent was delivery system was advanced to the intended site at the transverse-sigmoid sinus junction without difficulty.Of note, the device was advanced through a guiding catheter for the entirety of the course to the transverse sinus.Upon attempting to deploy the stent after removal of the safety, the rotating thumb wheel was noted to be making an atypical sound, and there was no evidence of stent deployment.The delivery system was removed, and inspection revealed no evidence of damage.Fluoroscopy was then performed along the length of the guide catheter, demonstrating the stent to be prematurely deployed within the catheter.The catheter was removed from the body, the stent was removed from the catheter, and the guide catheter was then replaced into position.A second 7 mm x 60 mm everflex stent was deployed without difficulty at the intended site.Procedure length was increased, but there was no adverse effect on the patient nor need for prolonged hospitalization.Fda safety report id #(b)(4).

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): EV3, INC.; plymouth MN
• MDR Report Key: 10396547
• MDR Text Key: 203134828
• Report Number: MW5096041
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2022
• Device Catalogue Number: EVD35-07-060-150
• Device Lot Number: A911415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Weight: 113