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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEM, INC. ENDOMAXX ESOPHAGEAL STENT

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MERIT MEDICAL SYSTEM, INC. ENDOMAXX ESOPHAGEAL STENT Back to Search Results
Catalog Number MAXX-2315
Device Problem Fracture (1260)
Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Stenosis (2263)
Event Date 10/10/2017
Event Type  Injury  
Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account reports the stent had fractured to the point that tissue ingrowth occurred.The physician placed another stent to treat the patient.
 
Manufacturer Narrative
The suspect device was returned for evaluation.The stent was found to be fractured however the complaint of tissue ingrowth could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
 
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Brand Name
ENDOMAXX ESOPHAGEAL STENT
Type of Device
ESOPHAGEAL STENT
Manufacturer (Section D)
MERIT MEDICAL SYSTEM, INC.
14646 kirby drive
houston TX 77047
Manufacturer (Section G)
MERIT MEDICAL SYSTEM, INC.
14646 kirby drive
houston TX 77047
Manufacturer Contact
casey hughes, ms, cqe, csqp
1600 merit parkway
south jordan, UT 94095
8012531600
MDR Report Key6997866
MDR Text Key90930704
Report Number3010665433-2017-00064
Device Sequence Number1
Product Code ESW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111611
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/10/2017
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 No Information
Device Catalogue NumberMAXX-2315
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/10/2017
Initial Date FDA Received11/02/2017
Supplement Dates Manufacturer Received12/18/2017
Supplement Dates FDA Received01/05/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age57 YR
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