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

Model Number 22923

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Numbness (2415)

Event Date 07/04/2011

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.The patient claimed numbness in the right leg.

Manufacturer Narrative

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.No further updates have been provided, if any further information is provided a follow up report will be submitted.The other reports related to the observational study are: 1219977-2014-00055, -00056, -00057, -00058, -00060, -00061, -00062, -00063, -00064, -00070, -00074, -00077, -00098.

• Brand Name: ADVANTA VXT GRAFT
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: lori gosselin, sr specialist ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3688020
• MDR Text Key: 18310005
• Report Number: 1219977-2014-00059
• 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: 10/05/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: 22923
• Device Catalogue Number: 22923
• Device Lot Number: AK07301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2011
• 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): Other
• Patient Age: 74 YR