MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ADVANTA VXT VASCULAR GRAFTS GREATER OR EQUAL TO 6MM; PROSTHESIS, VASCULAR GRAFT GREATER OR EQUAL TO 6MM

Model Number 22027

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 07/03/2014

Event Type  Injury  

Event Description

Patient had by-pass surgery (subclavian-femoral artery) and left femoral artery endoarterectomy in the same session.A few days after discharge, the patient fell down.A family physician reported a hematoma in the subclavian area, so the surgeon operated again to clean the area.The hematoma was easily drained.He then checked the subclavian anastomosis, which was not damaged.The graft was not stretched and there was no tension on the graft.After a few hours the patient was re-hospitalized for a major hemorrhage.The surgeon operated again and found the graft completely pulled out from the anastomotic site.The suture remained on the vessel, having gone completely through the graft.He removed the graft, and did not replace it.The patient was discharged.

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

• Brand Name: ADVANTA VXT VASCULAR GRAFTS GREATER OR EQUAL TO 6MM
• Type of Device: PROSTHESIS, VASCULAR GRAFT GREATER OR EQUAL TO 6MM
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: theresa morin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645237
• MDR Report Key: 4029632
• MDR Text Key: 4883214
• Report Number: 1219977-2014-00235
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K992960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 22027
• Device Catalogue Number: 22027
• Device Lot Number: 10913594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention