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

Model Number T510

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

Patient Problems Congestive Heart Failure (1783); High Blood Pressure/ Hypertension (1908); Mitral Valve Stenosis (1965)

Event Date 01/23/2013

Event Type  Injury  

Manufacturer Narrative

Citation: thorac cardiovasc surg.2014 apr;62(3):261-4.Doi: 10.1055/s-0032-1333137.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) female patient with mitral valve regurgitation secondary to infective endocarditis who underwent implant of a 29 mm medtronic hancock ii (serial number not provided).Twelve years following the implant, echocardiogram revealed stenosis with an increased mean gradient of 31 mmhg.Congestive heart failure with a systolic pulmonary artery pressure of 78 mmhg due to increased pulmonary vascular resistance was noted.Cardiopulmonary bypass (cpb) was performed and the valve was replaced with a mechanical valve.No additional adverse patient effects were reported.

Event Description

Additional information received from the physician/author stated that the 12 years of implant period was acceptable in terms of the device durability.

Manufacturer Narrative

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.

• 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 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: 6501368
• MDR Text Key: 73074996
• Report Number: 2025587-2017-00606
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2017

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: T510
• Device Catalogue Number: T510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 04/18/2017
• Supplement Dates Manufacturer Received: Not provided; 05/18/2017
• Supplement Dates FDA Received: 05/19/2017; 10/03/2017
• 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: 35 YR