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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. AEROMINI®.STENT, TRACHEOBRONCHIAL; TRACHEOBRONCHIAL STENT
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MERIT MEDICAL SYSTEMS, INC. AEROMINI®.STENT, TRACHEOBRONCHIAL; TRACHEOBRONCHIAL STENT Back to Search Results
Catalog Number AERO615
Device Problems Break (1069); Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/04/2019
Event Type  malfunction  
Manufacturer Narrative
The suspect device is not expected to return.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that during a tracheobronchial stent implant procedure, the actual stent deployment and positioning was considered unacceptably by the clinician.The clinician decided to remove the stent and re-deploy a new one.During stent removal with biopsy forceps, a small piece of the metal stent detached.All parts of the stent were successfully removed from the patient with no additional consequences to report.
 
Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint 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
AEROMINI®.STENT, TRACHEOBRONCHIAL
Type of Device
TRACHEOBRONCHIAL STENT
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
14646 kirby drive
houston TX 77047
MDR Report Key9501097
MDR Text Key185593514
Report Number3010665433-2019-00086
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
PMA/PMN Number
K181200
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberAERO615
Was Device Available for Evaluation? No
Date Manufacturer Received03/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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