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

Model Number UNKNOWN

Device Problem Material Perforation (2205)

Patient Problems Calcium Deposits/Calcification (1758); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Medtronic received information via literature review that a (b)(6) male patient underwent successful implant of a medtronic mitral bioprosthetic valve (model/serial not reported).Approximately 27 years postimplant, the patient presented with exertional dyspnea.Transthoracic echocardiography (tte) revealed moderate mitral stenosis and regurgitation.Transesophageal echocardiography (tee) showed moderate calcification on the leaflets, three mitral regurgitation jets, and a perforation with additional paravalvular defect.In a reoperation the mitral valve was explanted and successfully replaced with a medtronic ats mechanical prosthesis.No additional adverse patient effects were reported.Macroscopic examination of the explanted mitral prosthesis revealed a leaflet perforation.The article concluded highlighting the long-term durability of this valve in the mitral position.

Manufacturer Narrative

(b)(4).Title: very long-term durability of hancock ii porcine bioprosthesis on mitral position evaluation with real-time three-dimensional transesophageal echocardiography authors: cüneyt toprak, mehmet özkan, macit kalçik, sinan cersit, mehmet altug tuncer citation: arch turk soc cardiol 2014;42(5):497 (doi: 10.5543/tkda.2014.57418).(b)(4).

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.

Event Description

Requests for additional information provided no further details.

Manufacturer Narrative

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

• Brand Name: HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE
• 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: 4923785
• MDR Text Key: 19643960
• Report Number: 2025587-2015-00761
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P980043
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2015
• Initial Date FDA Received: 07/18/2015
• Supplement Dates Manufacturer Received: 07/27/2015
• Supplement Dates FDA Received: 09/18/2017
• 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: 00057 YR