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

Model Number 995

Device Problems Gradient Increase (1270); Incomplete Coaptation (2507)

Patient Problems Calcium Deposits/Calcification (1758); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)

Event Date 11/26/2016

Event Type  Injury  

Manufacturer Narrative

Citation: kuo et al.Melody valve implantation within freestyle stentless porcine aortic heterograft.Catheterization and cardiovas cular interventions.Epublished nov 26, 2016 earliest 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 these observations have been previously reported.(b)(4).

Event Description

Medtronic received information via literature regarding implant of a medtronic melody valve into a medtronic freestyle heterograft.All data was collected from a single center between the time frame of june 2012 and june 2015.The study population included 22 patients (gender not provided, mean age 14.5 years, 52.4 kg) with previously implanted freestyle heterografts, 19 of which were implanted with a melody valve.No serial numbers were provided.Among the 22 patients with a previously implanted freestyle these adverse events occurred: increased gradients, calcification (7 mild, 8 moderate, 4 severe), 15 pulmonary stenosis, 1 pulmonary insufficiency, 3 coronary compression, 3 pulmonary stenosis/insufficiency combined.It was also noted that the heterograft leaflets were noted as thickened or barely mobile.Of these 22 patients, 19 required intervention with implant of a melody valve.Among the 19 patients implanted with a melody valve these adverse effects occurred: 2 balloon deflation recoil from the ensemble delivery system which required an additional stent, 1 balloon rupture of the ensemble delivery system due to inadvertent over-inflation which required surgical removal of the delivery system, and 5 valves had mild pulmonary insufficiency at 36 months post-implant.No additional adverse patient effects were reported.

Manufacturer Narrative

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: 6213548
• MDR Text Key: 63549219
• Report Number: 2025587-2016-02100
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• 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
• Date Manufacturer Received: 12/02/2016
• 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: 15 YR
• Patient Weight: 52