MAUDE Adverse Event Report: ATRIUM MEDICAL ATRIUM GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Problem Insufficient Information (3190)

Patient Problems Anemia (1706); Edema (1820); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Occlusion (1984); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number, or sample was provided.The article concluded significantly better patency rates were achieved with the hbd than with ptfe at 3 years, but the difference was no longer statistically significant at 5 years.The incidence of major limb amputation, however, was significantly greater in the ptfe group compared with the hbd group at both 3 and 5 years of follow up.

Event Description

Article received: devine, c.A.(2004).Heparin-bonded dacron or polytetrafluorethylene for femoropopliteal bypass: five-year results of a prospective randomized multicenter clinical trial.Journal of vascular surgery, 40, 924-931.The purpose of this is to compare heparin-bonded dacron (hbd) with polytetrafluoroethylne (ptfe) in a randomized multicenter clinical trial.Per the article: adverse events in the ptfe group included: hematoma, infection, lymphedema, cellulitis, hemorrhage, pyrexia, anemia, chest infection, occlusions, stenosis and amputation.

• Brand Name: ATRIUM GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7051551
• MDR Text Key: 92718090
• Report Number: 3011175548-2017-00304
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• 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