MAUDE Adverse Event Report: MEDTRONIC, INC. STENT BIL VISIPRO 0.35; CATHETER, BILIARY, DIAGNOSTIC

Lot Number LOG8466212

Device Problem Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2023

Event Type  malfunction  

Event Description

Provider was attempting to stent the left subclavian artery and the stent came out of the stent delivery system into the subclavian/aorta unintentionally.

• Brand Name: STENT BIL VISIPRO 0.35
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 16888171
• MDR Text Key: 314869330
• Report Number: MW5117355
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: LOG8466212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2023
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White