MAUDE Adverse Event Report: MERIT MEDICAL INC ALVEOLUS ESOPHAGEAL STENT

Device Problem Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/22/2008

Event Type  malfunction  

Event Description

Unable to remove esoph stent.Stent is still embedded.Used rat tooth, alligator forceps and snare and could not remove it.A portion of the device remains in the patient and the hospital has the pieces that could be removed.

• Brand Name: ALVEOLUS ESOPHAGEAL STENT
• Type of Device: ESOPHAGEAL STENT
• Manufacturer (Section D): MERIT MEDICAL INC; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 5540352
• MDR Text Key: 41628199
• Report Number: 5540352
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2016,03/02/2016

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 Operator: Other
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR