MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT AP360 HEART VALVE; HEART-VALVE, MECHANICAL

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Stroke/CVA (1770); Death (1802); Endocarditis (1834); Hemorrhage/Bleeding (1888); Thrombus (2101); Regurgitation (2259); Hemolytic Anemia (2279); Thromboembolism (2654)

Event Date 11/18/2013

Event Type  Death  

Manufacturer Narrative

Requests for additional information provided no further details.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

Medtronic received information that a study was performed to retrospectively analyze the 20-year clinical results of patients implanted with a medtronic open pivot mechanical heart valve between may 1992 and december 2011 at one institution.The study population included 1,382 patients (predominantly male; mean age 61 years), implanted with a total of 1,520 valves (model/serial not reported)in four cardiac positions: 1,012 aortic, 473 mitral, 26 tricuspid, 9 pulmonary.The 99% complete follow-up totaled 10,527 patient-years (range 12 to 244 months).Across all patients, a total of 550 deaths occurred, including 73 early deaths (within 90 days of implant) and 477 late deaths (more than 90 days following implant).Of early deaths, 8 were considered valve-related: stroke (n=2), bleeding (n=2), valve thrombosis (n=1), hemolysis (n=1), endocarditis (n=1), and sudden death (n=1).Of late deaths, 49 were considered valve-related: sudden death (n=20), anticoagulation-related hemorrhage (n=14), endocarditis (n=7), thromboembolism (n=5), and valve thrombosis (n=3).Other non-death adverse events included: thromboembolism (n=126), major bleeding (n=106), paravalvular leakage (n=32), valve thrombosis (n=29), and endocarditis (n=22).Fifty patients were reoperated due to valve-related issues: paravalvular leakage (n = 20), endocarditis (n = 15), valve thrombosis (n = 14), and pannus formation (n = 2).No additional adverse patient effects were reported.The article concluded the 20-year experience demonstrated excellent clinical outcomes with no structural valve failure.

Manufacturer Narrative

The devices were not returned to medtronic.B)(4).Title: twenty-year single-center experience with the medtronic open pivot mechanical heart valve authors: guido j.Van nooten, md, phd, thierry bov_e, md, yves van belleghem, md, katrien franc¸ois, md, phd, frank caes, md, guy va ndenplas, md, michel de pauw, md, and yves taeymans, md, phd citation: the annals of thoracic surgery, v.97, 4:1306¿13 (doi: http://dx.Doi.Org/10.1016/j.Athoracsur.2013.11.035) event date unknown.

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: OPEN PIVOT AP360 HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• 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: 4851280
• MDR Text Key: 14380678
• Report Number: 3008592544-2015-00020
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2015
• 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): Death; Life Threatening; Required Intervention
• Patient Age: 00061 YR