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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
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/23/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event or Problem 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.
 
Additional 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
Common Device Name
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
Report Number1721504-2020-00099
Device Sequence Number16389236
Product Code DSY
UDI-Device Identifier00884450320563
UDI-Public00884450320563
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K172637
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 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
Operator of Device 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 Received by Manufacturer 11/24/2020
Supplement Date Received by Manufacturer04/18/2021
Initial Report FDA Received Date12/01/2020
Supplement Report FDA Received Date04/28/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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