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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL INC ALVEOLUS ESOPHAGEAL STENT

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MERIT MEDICAL INC ALVEOLUS ESOPHAGEAL STENT Back to Search Results
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.
 
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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 Key5540352
MDR Text Key41628199
Report Number5540352
Device Sequence Number1
Product Code ESW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 FDA03/03/2016
Event Location Hospital
Date Report to Manufacturer03/03/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/31/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
Patient Age70 YR
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