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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA VXT W/GDS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

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ATRIUM MEDICAL CORPORATION ADVANTA VXT W/GDS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Model Number 22114
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inflammation (1932)
Event Date 08/08/2019
Event Type  Injury  
Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
 
Event Description
After graft transplantation, there was inflammation.The user assumed that the problem occurred elsewhere rather than the graft problem.
 
Manufacturer Narrative
Analysis: the details indicate that swelling occurred after the procedure and if other devices from the same lot had been reported for swelling issues.A review of our complaint log indicates that there have been no other complaints related to swelling from the same production lot of graft going back historically 3 years.A thorough review of the device history records for this graft lot was conducted.The device lot in question met all quality and performance testing requirements and no non-conformances were noted during the build of the product related to the complaint.The instructions for use in the adverse reaction section mentions the following in regards to complication with the use of any vascular graft include the following: ¿complications that may occur in connection with the use of any vascular graft include, but are not limited to; thrombosis, stenosis, formation of pseudoaneurysm due to excessive needle punctures, peri-graft hematoma formation, peri-graft seroma formation, excessive needle hole bleeding or weeping, infection, swelling of tissue, suture hole elongation, mechanical disruption, material separation, delamination or tearing of the graft material, suture line or host vessel which may result in extreme blood loss, loss of limb function, steal syndrome, loss of limb or possible death.The patient should be advised to contact the physician should an adverse reaction occur.¿ conclusion: based on the review of the device history records and product complaint details atrium medical corporation cannot conclude that the swelling was directly related to the advanta graft.
 
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Brand Name
ADVANTA VXT W/GDS
Type of Device
PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH 03054
MDR Report Key8910258
MDR Text Key154872613
Report Number3011175548-2019-00884
Device Sequence Number1
Product Code DSY
UDI-Device Identifier00650862221145
UDI-Public00650862221145
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 08/20/2019
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
Device Operator Health Professional
Device Expiration Date04/10/2022
Device Model Number22114
Device Catalogue Number22114
Device Lot Number443557
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 08/13/2019
Initial Date FDA Received08/20/2019
Supplement Dates Manufacturer Received09/10/2019
02/01/2021
Supplement Dates FDA Received09/17/2019
02/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age84 YR
Patient Weight61
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