MAUDE Adverse Event Report: BOSTON SCIENTIFIC WALLFLEX ESOPHAGEAL STENT

Catalog Number 1674

Device Problems Hole In Material (1293); Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 05/12/2014

Event Type  Injury  

Event Description

Esophageal stent was found to have "2 adjacent pinpoint holes." required to be replaced.Physician reported stent was defective.Indication for procedure: persistent esophageal leak.

• Brand Name: WALLFLEX ESOPHAGEAL STENT
• Type of Device: WALLFLEX ESOPHAGEAL STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC; natick 01760 153
• MDR Report Key: 3893800
• MDR Text Key: 21244972
• Report Number: MW5036780
• Device Sequence Number: 1
• Product Code: ESW
• 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: 06/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1674
• Device Lot Number: 16822786
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 83