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

Model Number 22925

Device Problem Occlusion Within Device (1423)

Patient Problems Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Necrosis (1971); Stenosis (2263)

Event Date 09/01/2011

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.There were multiple sites of stenosis and occluded 90% from superficial femoral artery to popliteal artery.The patient underwent bypass procedure in left leg for arteriosclerosis.The patient had treatment for necrosis of left leg at another hospital.On (b)(6) 2011, the patient's blood pressure dropped suddenly.The patient expired on (b)(6) 2011 of chronic cardiac failure during dialysis.

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, 00070, 00074, 00077, 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: 3688013
• MDR Text Key: 4289508
• Report Number: 1219977-2014-00064
• 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: 03/30/2012

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: 09/30/2015
• Device Model Number: 22925
• Device Catalogue Number: 22925
• Device Lot Number: AJ3004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2012
• 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): Required Intervention
• Patient Age: 92 YR
• Patient Weight: 47