MAUDE Adverse Event Report: EV3 INC./ MEDTRONIC, INC. PERIPHERAL STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number PRB35-06-120-120

Device Problem Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2021

Event Type  Injury  

Event Description

Patient undergoing angiogram of left lower extremity.Incomplete deployment of a 6 x 120 mm everflex stent due to stent malfunction in the external common iliac artery region.Patient had to go to the operating room for removal of the sheath, residual stent and repair of sheath removal site of right common femoral artery.Fda safety report id # (b)(4).

• Brand Name: PERIPHERAL STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): EV3 INC./ MEDTRONIC, INC.; plymouth MN 55442
• MDR Report Key: 11404185
• MDR Text Key: 234930840
• Report Number: MW5099736
• Device Sequence Number: 1
• Product Code: NIP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2023
• Device Catalogue Number: PRB35-06-120-120
• Device Lot Number: B112589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 97