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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT
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MEDTRONIC IRELAND VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT Back to Search Results
Model Number VS-402
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)
Date of Event 03/30/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
During index procedure a vena seal closure system was used to treat a lesion located in the great saphenous vein 1.Approximately twenty seven days post procedure, patient suffered from a pulmonary embolism secondary to deep vein thrombosis.The event was treated with medication.Patient recovered.
 
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Brand Name
VENA SEAL CLOSURE SYSTEM
Common Device Name
AGENT, OCCLUDING, VASCULAR, PERMANENT
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI 
MDR Report Key11698937
Report Number9612164-2021-01558
Device Sequence Number3500069
Product Code PJQ
UDI-Device Identifier00643169986268
UDI-Public00643169986268
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
P140018
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/21/2021
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? No
Operator of Device Health Professional
Device Expiration Date04/30/2022
Device Model NumberVS-402
Device Catalogue NumberVS-402
Device Lot Number59274
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/12/2021
Initial Report FDA Received Date04/21/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age47 YR
Patient Weight102
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