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

Model Number FR995-27

Device Problems Material Separation (1562); Material Deformation (2976)

Patient Problems Wound Dehiscence (1154); Host-Tissue Reaction (1297); Aneurysm (1708); Aortic Insufficiency (1715); Aortic Valve Stenosis (1717); Dyspnea (1816); Hernia (2240)

Event Date 03/18/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Additional patient codes provided in the additional codes section conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 7 years and 5 months post implant of this 27mm full bioprosthetic aortic root valve, the patient reported shortness of breath with exertion.Repeat cardiac evaluation (cardiac catheterization and transesophageal echocardiogram) demonstrated severe aortic insufficiency.Computed tomography of the patient's chest revealed a 5.3 cm aortic root aneurysm.Ultimately, 7 years and 11 months post implant of the bioprosthetic aortic root, it was replaced with a bioprosthetic valve of the same size but different model.During the surgical procedure, it was noted that the bioprosthetic root was "aneurysmal", with "some degree" of the aneurysmal portion being subvalvular.The surgeon noted false aneurysm or dehiscence of the bioprosthetic root from the native aorta, at the level of the sinotubular junction.Of note, the insufficiency was noted as central, not paravalvular.The left and right coronary cusps were elevated away from the inflow sewing ring of the valve.Fibrotic pannus was present on the inflow portion of the valve, resulting in mild stenosis.The surgeon elected to resect the leaflets, but left the remaining portion of the valve intact.The surgeon successfully performed a root remodeling procedure with a non-medtronic graft and implanted a new bioprosthetic aortic valve.No additional adverse patient effects were reported.

• 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: 8542710
• MDR Text Key: 142863571
• Report Number: 2025587-2019-01328
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00681490265942
• UDI-Public: 00681490265942
• 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
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2015
• Device Model Number: FR995-27
• Device Catalogue Number: FR995-27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2019
• Date Device Manufactured: 01/13/2011
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 78