MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. ENDOMAXX ESOPHAGEAL STENT; PROSTHESIS, ESOPHAGEAL

Catalog Number MAXX-2310/A

Device Problem Torn Material (3024)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/05/2014

Event Type  Injury  

Event Description

It was reported that a stent was originally placed in a pt's esophagus to cover a 6cm defect that the physician thought might become a perforation.The pt was seen at a later date by a gi doctor for bleeding.The physician noticed clotting and blood coming from beneath the flares of the stent.The physician lifter the flares to investigate and the pt started to bleed.The pt was transferred to the operating room to treat the bleeding where the second physician placed an aortic stent to stop the bleeding.During the surgery the pt received nine units of blood.The esophageal stent was not removed because of the bleeding.The esophagal stent was removed after the pt recovered from surgery.During removal of the esophageal stent, at a later date, the suture broke and the end of the stent fractured.A ct was performed after the esophageal stent removal.The scan showed no extravasation and no perforation from the stent.The hospital was unable to determine the root cause of the bleeding.No further injury of harm to the pt was reported.Pt stay in the hospital was 90 days.

Manufacturer Narrative

No device is expected to be returned for investigation.The device history record was reviewed and no exception documents were found.The complaint database was reviewed and no similar complaints for this lot number were found.Because the unit was not returned, the root cause could not be determined.If the device is returned in the future this investigation will be reopened and an add'l follow up submitted.

• Brand Name: ENDOMAXX ESOPHAGEAL STENT
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; south jordan UT
• Manufacturer Contact: jerry mcphie ; 1600 west merit pkwy.; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 3876003
• MDR Text Key: 20976987
• Report Number: 1721504-2014-00110
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: MAXX-2310/A
• Device Lot Number: IPX0643U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2014
• Initial Date FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention