MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION OPEN PIVOT MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Death (1802); Hemorrhage/Bleeding (1888); Transient Ischemic Attack (2109); Pericardial Effusion (3271)

Event Date 01/03/2005

Event Type  Death  

Event Description

Medtronic received information that a study was performed to retrospectively analyze the rate of thromboembolic events and other val ve-related complications with mechanical heart valves implanted in the mitral position.The study population included 177 patients (predominantly female; mean age 58 years), implanted with medtronic open pivot mechanical heart valves (25mm=11, 27mm=66, 29mm=52, 31mm=33, 33mm=15; serials not reported) between june 1992 and june 2002 at one institution.Follow-up data represented 724 total patient-years, with an average of 3.25 years per patient.There were a total of five hospital deaths, which included two patients in end-stage valvulopathy who died in the operating room and three patients who died in the intensive care unit (icu) of cardiogenic, septic, and multiorgan failure respectively.There were 16 revision cases during the hospitalization: 4 for bleeding and 12 for pericardial effusion requiring pericardial drainage.Early complications included three transient cerebrovascular accidents and two strokes.Late complications included three transient cerebrovascular ischemic accidents.No additional adverse patient effects were reported.No other complications such as paravalvular leak, valve dysfunction, thrombosis, or valve explant occurred.The article concluded the valve demonstrated low rates of bleeding, thromboembolic, and other valve-related complications.

Manufacturer Narrative

(b)(4).Title: title: 10-year experience with the ats mechanical valve in the mitral position authors: constantin stefanidis, md, albert m.Nana, md, didier de cannière, md, phd, martine antoine, md, jean-luc jansens, md, chi-hoang huynh, md, and jean-louis le clerc, md citation: ann thorac surg 2005;79:1934¿8 (doi:10.1016/j.Athoracsur.2005.01.002).(b)(4).

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.

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 MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 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: 4854270
• MDR Text Key: 5868812
• Report Number: 3008592544-2015-00022
• 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: 06/18/2015
• 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?: 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; Hospitalization; Required Intervention
• Patient Age: 00058 YR