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

Model Number 995

Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Pannus (1447); Aneurysm (1708); Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Thrombus (2101); Pseudoaneurysm (2605)

Event Date 04/25/2016

Event Type  Injury  

Manufacturer Narrative

Conclusion: product analysis is in progress.Results of the product analysis will be submitted in a supplemental report.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 8 years 3 months following implant of this bioprosthetic aortic valve and root, the patient presented with class iv angina.Catheterization demonstrated a 99% stenosis in the origin of the graft of the left anterior descending (lad) artery, with 75% diffuse stenosis in the graft to the right coronary artery.Separate stents were placed via catheters in the lad and right coronary arteries with 0% residual stenosis in both instances.Subsequently, the patient presented with a 6.1 cm aneurysm.No intervention and no other adverse patient effects were reported at that time.Additional information was received that 9 years and 7 months post implant of this bioprosthetic valve, the valve was explanted and replaced with a non-medtronic conduit due to an aortic aneurysm.Echocardiogram reported stenosis and mild to moderate regurgitation were present.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual inspection revealed that two pieces of tissue were received; a freestyle and a vein graft.The free edge of the sewing cloth on the valve showed explant damage, therefore it could not be confirmed if the cloth was everted.Green multifilament and blue monofilament sutures were found sutured along the damaged sewing cloth and on multiple areas of the aortic wall of both pieces.The pieces appeared to have been cauterized during explant.All the leaflets¿ commissures were intact and were still attached to the aortic wall.Traces of pannus were found at the left right commissure.All leaflets (inflow) were stiff and thickened by thrombus.However, the lunulas of all three leaflets were flexible and appeared wavy.Visible pannus lined the margin of attachment of the right coronary cusp encroaching to the tunica approximately 1 mm to 3 mm.The tissue wall of the valve was thinned out.Evident pseudoaneurysm was observed at the left aortic wall above the left coronary sinus.It appeared to be adjacent to the left coronary cusp leaflet attachment.It appeared that the right coronary and non-coronary had been modified.The right coronary sinus appeared to have been excised during modification.A small perforation (possibly pseudoaneurysm) was observed on the non-coronary wall.Blue monofilament suture was found attached to the small perforation.Radiography did not reveal any evidence of calcification in the valve tissue.A review of the device history record (dhr) could not be performed as the serial number was not provided.The transthoracic echocardiograms reviewed prior to explant revealed evidence of saphenous vein graft disease and aortic root aneurysm.The underlying aortic valve lesion precipitating aortic valve replacement is not known.However, patients with aortic stenosis and coronary artery disease often have risk factors for aortic aneurysm, including hypertension and dyslipidemia.Patients with a bicuspid aortic valve are at risk of bicuspid aortopathy, which can progress after aortic valve replacement.Mild and then mild-to-moderate aortic regurgitation were noted on serial echocardiography.With only mild focal sclerosis of the aortic bioprosthesis, a likely etiology is aortic root dilation leading to leaflet malcoaptation of the stentless valve leaflets.Based on the echo over-read and the limited information available, a root cause of the stenosis cannot be determined.If information is provided in the future, a supplemental report will be issued.

• 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: 6773802
• MDR Text Key: 82046678
• Report Number: 2025587-2017-01336
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2017
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 117