MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC VICI; STENT, ILIAC

Lot Number 19060030

Device Problems Entrapment of Device (1212); Migration (4003)

Patient Problems Bacterial Infection (1735); Dyspnea (1816); Cardiac Tamponade (2226); Device Embedded In Tissue or Plaque (3165); Pericardial Effusion (3271)

Event Date 06/29/2020

Event Type  Injury  

Event Description

Patient had a vici (left common/external iliac) & wallstent (left common femoral vein) placed in (b)(6) 2019.In (b)(6) she presented with progressive dyspnea on exertion and imaging found a migrated stent in the right atrium associated a pericardial effusion.She underwent surgery but only 9 cm of the vici stent was able to be removed; the rest of the stent remained stuck within the ivc wall.Then in (b)(6) of 2020 she again presented with worsening dyspnea on exertion and was found to be a pericardial tamponade requiring pericardiocentesis.Currently, patient now has effusive-constrictive pericarditis as a result of these procedures.Fda safety report id # (b)(4).

• Brand Name: BOSTON SCIENTIFIC VICI
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 19060030
• MDR Report Key: 10407189
• MDR Text Key: 203155278
• Report Number: MW5096067
• Device Sequence Number: 1
• Product Code: NIO
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 19060030
• 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): Hospitalization; Life Threatening
• Patient Age: 48 YR
• Patient Weight: 139