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

Model Number 995J25

Device Problem Structural Problem (2506)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Congestive Heart Failure (1783)

Event Date 01/06/2015

Event Type  Injury  

Event Description

Medtronic received information via literature that an (b)(6) year old male patient underwent a successful implantation of a medtronic 25-mm stentless aortic bioprosthetic valve (serial not reported).Twelve years postoperative the patient had significant dyspnea on exertion requiring multiple hospital admissions for congestive heart failure.Transthoracic echocardiography demonstrated severe structural valve deterioration of the prosthetic valve with mild to moderate stenosis and severe aortic insufficiency.Subsequently, the patient underwent a transapical approach procedure to implant a small non-medtronic bioprosthetic valve inside the previously implanted valve.The upper crown of the new valve was opened just above the aortic annulus to engage the degenerated leaflets of the previous valve, and pulled slightly ventricular before releasing the lower crown and sealing skirt to fully deploy the new valve.Postprocedural assessment confirmed an excellent result after valve-in-valve implantation, with no residual aortic insufficiency.Postoperatively the patient did well without complication.No additional adverse patient effects were reported.

Manufacturer Narrative

(b)(4).Title: symetis valve implantation in failing freestyle with close proximity between coronary ostia and annulus authors: jeevan nagendran, md, phd, jorge catrip, md, pantelis diamantouros, md, patrick teefy, md, bob kiaii, md, ian chan, md, aas hish goela, md, david m.Holzhey, md, and michael w.A.Chu, md, med citation: ann thorac surg 2015;99:e87¿8.

Manufacturer Narrative

Conclusion: no device was returned and no unique device identifier numbers were provided.Based on the available information a review of the device history record could not be performed and root cause could not be identified.

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 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: 4913872
• MDR Text Key: 6055945
• Report Number: 2025587-2015-00743
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 995J25
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2015
• 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: 00080 YR