MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION VALVE HANCOCK II MITRAL 31MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number T510-31H

Device Problems Gradient Increase (1270); Occlusion Within Device (1423)

Patient Problems Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)

Event Date 09/14/2014

Event Type  Injury  

Event Description

Medtronic received information that another manufacturer¿s 29 millimeter (mm) replacement heart valve was implanted valve-in-valve into a 31mm medtronic bioprosthetic mitral heart valve due to high gradients, severe central regurgitation and stenosis.It was reported that the internal diameter of this device was 26mm at the time of the procedure.No subsequent adverse patient effects were reported.

Manufacturer Narrative

Additional information was received that the physician was unable to provide any further details regarding the event.Without the serial number of the device, no device history review can be performed.Without the return of the device, no conclusion to root cause can be obtained.

Manufacturer Narrative

The device remains implanted.It was reported that the details regarding the device serial number, date of implant and patient demographics would be made available to medtronic.To date, the information has not been provided despite ongoing follow-up requests.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALVE HANCOCK II MITRAL 31MM
• 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: 4450371
• MDR Text Key: 5394988
• Report Number: 2025587-2015-00089
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T510-31H
• Device Catalogue Number: T510-31H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2015
• 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