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

Model Number FR995-23

Device Problem Structural Problem (2506)

Patient Problems Cardiac Arrest (1762); Death (1802); Regurgitation (2259)

Event Date 05/30/2014

Event Type  Death  

Event Description

Medtronic received information that this patient had a history of aortic regurgitation for the last 4-5 years however the patient refused reoperation.It was noted by the physician that the degree of regurgitation remained the same however enlargement of the heart had increased.Recently, 17 years post implant of this bioprosthetic aortic root valve, the patient had a cardiac arrest due to regurgitation and had a cardiopulmonary arrest during hospitalization.The patient was connected to percutaneous cardiopulmonary support (pcps).The physician determined at that time the patient was unable to have any surgical intervention.However, the patient's recovered slightly and the physician decided to perform the aortic valve replacement procedure.The valve had been implanted by sub-coronary technique.During the explant, the leaflets of the chronic valve were excised and one of the bases remained because of hard adhesion.Another manufacturer's tissue valve was implanted on the base of the previous valve.The operation was successfully completed, however the patient expired the next day due to multiple organ failure.Portions of the valve were returned for analysis (leaflets).The physician noted a tear in one of the cusps upon explant, however no vegetation was found.

Manufacturer Narrative

A portion of the valve has been returned and is pending analysis.Upon completion of analysis, this report will be updated and a supplemental report will be filed.(b)(4).

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, three excised leaflets were returned in separate vials labeled with the corresponding leaflet.All excised leaflets were slightly stiff but flexible except where visible mineralization or host tissue were present.Tissue deterioration was observed on all leaflets along the excised commissural edge or belly of the leaflet.A tear through the belly of the left cusp appeared to be due to mineralization but increased in size during explant.Remnants of glistening off-white pannus remained attached to the inflow and outflow of the right cusp.Radiography showed mineralization in all excised leaflets.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Histopathology confirmed the clinically-observed leaflet degeneration was due to chronic structural deterioration with intrinsic calcification.There was no evidence of infection in the specimens examined.Based on the received information, histopathological evaluation, and the returned product analysis, the regurgitation was likely due to calcification/tissue fatigue that occurred over time.

• 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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 3895601
• MDR Text Key: 4423669
• Report Number: 2025587-2014-00420
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FR995-23
• Device Catalogue Number: FR995-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death
• Patient Age: 00078 YR