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

Catalog Number MAXX-1912/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2014

Event Type  malfunction  

Event Description

The user reported that the device tore approx four centimeters from the proximal end during removal from the patient.The user was unable to provide the part number or lot number of the device.The user stated this has happened two other times but has not provided any info for those events nor have they provided any add'l info for this event.No harm or injury was reported.

Manufacturer Narrative

Device eval: the suspect device is not expected to be returned for eval.The device history record and complaint database could not be reviewed as the user did not provide a lot number.The part number listed is an estimate.Implant and explant dates were not provided.Merit has attempted to obtain add'l info on (b)(4) 2014, (b)(4) 2014, (b)(4) 2014, and (b)(4) 2014.A follow up report will be submitted if add'l info becomes available.Conclusions: device not returned.

• Brand Name: ENDOMAXX ESOPHAGEAL STENT
• Type of Device: PROSTHESIS, ESOPHAEAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit pkwy.; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit pkwy.; south jordan UT 84095
• Manufacturer Contact: paul kennedy ; 1600 west merit pkwy.; south jordan, UT 84095 ; 8012084301
• MDR Report Key: 3784854
• MDR Text Key: 4374475
• Report Number: 1721504-2014-00014
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2014

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: Health Professional
• Device Catalogue Number: MAXX-1912/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2014
• Initial Date FDA Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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