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

Model Number T505

Device Problem Insufficient Information (3190)

Patient Problems Thrombus (2101); Vascular System (Circulation), Impaired (2572); Thromboembolism (2654)

Event Date 09/01/2006

Event Type  Injury  

Manufacturer Narrative

Citation: rizzoli g et al.Fifteen-year results with the hancock ii valve: a multicenter experience.J thorac cardiovasc surg.2006 sep;132(3):602-9, 609.E1-4.Doi:10.1016/j.Jtcvs.2006.05.03.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.(b)(4).

Event Description

Medtronic received information via literature regarding 15-year outcome of patients who received an aortic or mitral valve replacement with a medtronic hancock ii bioprosthesis.All data were collected from multiple centers between 1983 through 2002.The study population included 1,274 patients; aortic bioprosthetic valves were implanted in 809 patients (predominantly male; mean age 68.4 years), and mitral bioprosthetic valves in 484 patients (predominantly female; mean age 65.8 years).No serial numbers were provided.Among all patients, 194 valve-related deaths occurred, 112 of which were aortic patients and 82 of which were mitral patients.Valve-related death was defined as ¿death caused by structural valvular deterioration, nonstructural dysfunction, valve thrombosis, embolism, bleeding event, operated valvular endocarditis, or death related to reoperation of an operated valve.Sudden, unexplained, unexpected deaths of patients with an operated valve are included as valve related mortality.¿ no further details were provided regarding these death events.Among all patients, adverse events included: embolism, thrombosis, occlusion of the left coronary ostium, hemorrhage, endocarditis, dehiscence, aortic aneurysm/pseudoaneurysm with reoperation, and structural valve dysfunction (svd) which was defined as stenosis and/or incompetence.No additional adverse patient effects or product performance issues relating to the bioprostheses were reported.

• Brand Name: HANCOCK II AORTIC 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: 6985626
• MDR Text Key: 90507233
• Report Number: 2025587-2017-01951
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T505
• Device Catalogue Number: T505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2017
• 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: 66 YR