MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 995

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Hematoma (1884); Pericardial Effusion (3271)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

Citation: yonezu, k.Ruptured saphenous vein graft pseudoaneurysm successfully treated with covered stents.Cardiovasc interv and ther (2016) 31:161¿163 date of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information, it could not be determined whether this event has been previously reported.(b)(4).

Event Description

Medtronic received information via literature review of a (b)(6) year-old male patient with a history of aortic valve streptococcal infective endocarditis, root abscess and severe aortic regurgitation requiring emergent aortic root replacement with non-medtronic device.Twenty-two days later, an echocardiogram revealed left ventricular pseudoaneurysm with shunt flow from the left ventricle to the right atrium.Subsequently, the patient underwent a second aortic valve replacement to implant a medtronic freestyle bioprosthesis(serial number not provided) and coronary artery reconstruction.Eighteen days later, the patient presented with sudden onset chest pain.An echocardiogram revealed a hematoma, pericardial effusion, cardiac tamponade and right ventricle collapse.A computed tomography showed extravasation, hemopericardium, and pseudoaneurysm at the saphenous vein graft (svg) and right coronary artery (rca) anastomotic site.Angiography with percutaneous coronary intervention revealed a ruptured pseudoaneurysm at the svg-rca site.Guidewires were used to successfully deliver a covered stent and draining of the pericardial drainage was performed.The patient recovered with no additional adverse effects.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5687652
• MDR Text Key: 46160339
• Report Number: 2025587-2016-00792
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2016

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 Model Number: 995
• Device Catalogue Number: 995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 05/30/2016
• Supplement Dates Manufacturer Received: 05/02/2016
• Supplement Dates FDA Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 46 YR