MAUDE Adverse Event Report: MERIT MEDICAL SYSTEM INC. ENDOMAXX ESOPHAGEAL STENT 23 X 120; NONE

Catalog Number MAXX-2312

Device Problem Material Fragmentation (1261)

Patient Problems Hemorrhage/Bleeding (1888); Nausea (1970); Vomiting (2144)

Event Date 05/05/2014

Event Type  Injury  

Event Description

Client originally had the esophageal stent placed (b)(6) 2014.Patient returned to the hospital on (b)(6) 2014 with complaints of nausea associated with hematemesis.Ct of the chest showed the stent was in place.Patient had an egd on (b)(6) 2014 which showed the stent in place also.The client unfortunately had an episode of bleeding during the egd, requiring transfer to icu.The stent was removed on (b)(6) 2014.While the doctor was grasping the wire to remove the stent, the wire broke.The stent broke into three pieces.The physician was able to retrieve all three pieces.There was no harm to the patient.

• Brand Name: ENDOMAXX ESOPHAGEAL STENT 23 X 120
• Type of Device: NONE
• Manufacturer (Section D): MERIT MEDICAL SYSTEM INC.; south jordan 84095
• MDR Report Key: 3820569
• MDR Text Key: 4497944
• Report Number: MW5036159
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: MAXX-2312
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 89