MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ADVANTA VXT GRAFT

Model Number 22920

Device Problem Occlusion Within Device (1423)

Patient Problems Death (1802); Occlusion (1984); Pneumonia (2011); Thrombosis (2100)

Event Type  Injury  

Event Description

St.Jude medical found out of three cases of thrombotic occlusion in the literature obtained in april 16, 2012 from a clinical experiences of graft on chronic hemodialysis patients.After the occlusion occurred, the connection was re-created by connecting the patient's own blood vessels together, and the patient continued to undergo hemodialysis without any incident but expired of pneumonia.

Manufacturer Narrative

The reported event was from an observational study for a fem-pop bypass with a flared-end graft.A device history record review was performed and the device was found to have met all specifications.The sterilization records were reviewed and there were no deviations found during the process.Review of complaints does not show any similar reports related to a device failure.The report stated that the physician did not believe that the event was related to the product.The other reports are: 1219977-2014-00071 and 1219977-2014-00073.

• Brand Name: ADVANTA VXT GRAFT
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: lori gosselin, specialist ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3687994
• MDR Text Key: 4255364
• Report Number: 1219977-2014-00072
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K992958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2012

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 Date: 02/28/2015
• Device Model Number: 22920
• Device Catalogue Number: 22920
• Device Lot Number: AJ01909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2012
• Initial Date FDA Received: 02/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2010
• 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
• Patient Age: 77 YR