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

Model Number 22923

Device Problem Insufficient Information (3190)

Patient Problem Infarction, Cerebral (1771)

Event Date 11/29/2010

Event Type  Injury  

Event Description

The reported event was from an observational study for a femoral popliteal bypass surgery (fem-pop) with a flared-end graft.Patient had 2 devices one for the right lower extremity and one for the left lower extremity.On postoperative day 4, the patient developed cerebral infarction and has undergone rehabilitation.

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 related to the observational study are: 1219977-2014-00055, 00056, 00057, 00058, 00059, 00060, 00061, 00062, 00063, 00064, 00074, 00077, and 00098.

• 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: 3688010
• MDR Text Key: 4255368
• Report Number: 1219977-2014-00070
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K992960
• 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: 06/21/2012

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: 09/30/2015
• Device Model Number: 22923
• Device Catalogue Number: 22923
• Device Lot Number: AJ21008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2012
• Initial Date FDA Received: 02/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Required Intervention