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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. HERO; PROSTHESIS, VASCULAR GRAFT
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MERIT MEDICAL SYSTEMS INC. HERO; PROSTHESIS, VASCULAR GRAFT Back to Search Results
Model Number 00884450385685
Medical Device Problem Codes Material Separation (1562); Migration (4003)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 03/21/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.
 
Event or Problem Description
The account reports that the dialysis graft was successfully placed on (b)(6) 2019; in (b)(6) 2021, they found that the device tore and migrated to the ivc, and is lodged in the hip/pelvis area.Removal of the device is pending.
 
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Brand Name
HERO
Common Device Name
PROSTHESIS, VASCULAR GRAFT
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan UT 84095
MDR Report Key12747436
Report Number1721504-2021-00079
Device Sequence Number11884464
Product Code DSY
UDI-Device Identifier00884450385685
UDI-Public00884450385685
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K124039
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number00884450385685
Device Catalogue NumberHERO1001
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/08/2021
Initial Report FDA Received Date11/03/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
HERO 1003
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