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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. HERO; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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MERIT MEDICAL SYSTEMS INC. HERO; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Model Number 00884450320563
Device Problem Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2020
Event Type  Injury  
Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that the hero device disconnected from the titanium connection and migrated to the right ventricle.Component was partially removed on (b)(6) 2020.No patient injury to report.
 
Manufacturer Narrative
A crucial components of 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
HERO
Type of Device
PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan UT 84095
MDR Report Key10928955
MDR Text Key218999283
Report Number1721504-2020-00099
Device Sequence Number1
Product Code DSY
UDI-Device Identifier00884450320563
UDI-Public00884450320563
Combination Product (y/n)N
PMA/PMN Number
K172637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 11/24/2020
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 Model Number00884450320563
Device Catalogue NumberHERO1000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2020
Initial Date Manufacturer Received 11/24/2020
Initial Date FDA Received12/01/2020
Supplement Dates Manufacturer Received04/18/2021
Supplement Dates FDA Received04/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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