MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. VASCUGRAFT; PROSTHESIS, VASCULAR GRAFT

Model Number V1103003

Device Problem Torn Material (3024)

Patient Problem Thrombus (2101)

Event Type  Injury  

Event Description

Graft was implanted without issue.After implantation, it was reopened in the middle because the patient experienced a thrombus.When trying to re-sew the hole, the graft tore lengthwise.

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: VASCUGRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: theresa morin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645237
• MDR Report Key: 4121166
• MDR Text Key: 4942262
• Report Number: 1219977-2014-00317
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K000499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: V1103003
• Device Catalogue Number: V1103003
• Device Lot Number: 10844926
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• 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: 54 YR
• Patient Weight: 75