MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK II MITRAL 27MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number T510-27H

Device Problem Gradient Increase (1270)

Patient Problems Congestive Heart Failure (1783); Mitral Regurgitation (1964)

Event Date 07/20/2016

Event Type  Injury  

Manufacturer Narrative

Citation: schaefer u.First-in-man treatment of a degenerated mitral surgical valve with the mechanical expanding lotus¿ valve.Euro intervention.2016 jul 20;12(4):515-8.Doi: 10.4244/eijy15m09_08.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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature of a (b)(6) year-old female patient with mitral valvular endocarditis who underwent implant of a 27mm medtronic hancock ii (serial number not provided) in the mitral position.Ten years later, the patient presented with decompensated heart failure.Transesophageal echocardiogram (tee) revealed severe mitral regurgitation with a mean transvalvular gradient of 10 mmhg and an enlarged left atrium with preserved left ventricle function.A non-medtronic transcatheter valve was implanted valve-in-valve trans-apically.The mitral regurgitation was completely resolved.No additional adverse patient effects were reported.

• Brand Name: HANCOCK II MITRAL 27MM
• 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: 6777530
• MDR Text Key: 82166909
• Report Number: 2025587-2017-01352
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T510-27H
• Device Catalogue Number: T510-27H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• 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: 72 YR
• Patient Weight: 57