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

Model Number 30525

Device Problems Calcified (1077); Perivalvular Leak (1457); Structural Problem (2506)

Patient Problems Death (1802); Hemorrhage, Cerebral (1889); Thromboembolism (2654)

Event Date 02/01/2016

Event Type  Death  

Manufacturer Narrative

Title: the mosaic mitral valve bioprosthesis: a long-term clinical and hemodynamic follow-up citation: heart inst j 2016;43(1):13-9) authors: michele celiento, md, stefania blasi, md, andrea de martino, md, stefano pratali, md, aldo d.Milano, md, phd, uberto bortolotti, md.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether this event has been previously reported.(b)(4).

Event Description

Medtronic received information via literature review of a retrospective study performed to evaluate patients who underwent isolated mitral valve replacements from (b)(6) 1995 through (b)(6) 2011.The study population included 100 patients (predominantly male; mean age 73 ± years), all of which were implanted with a medtronic mosaic bioprosthetic valve (serial numbers not provided).Among all patients, 41 deaths occurred, 10 in-hospital deaths and 31 late deaths.Causes of death included: 8 cardiac, 2 cerebral embolism, 2 reoperation, and 1 unexpected.Of these deaths, five were deemed valve-related.Additionally, the following adverse events occurred: 4 thromboembolism, 1 cerebral hemorrhage, 3 cerebral embolic episodes, and 2 structural valve dysfunction (svd).Four patients required re-operation due to 2 svd (regurgitation, valve dehiscence, calcification and cuspal tear), 1 paravalvular leak (pvl), and 1 valve thrombosis.No additional adverse patient effects were reported.

Manufacturer Narrative

Corrected information: sex.

• Brand Name: MOSAIC 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: 5583474
• MDR Text Key: 42848215
• Report Number: 2025587-2016-00525
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P990064
• 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
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30525
• Device Catalogue Number: 30525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2016
• 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; Required Intervention
• Patient Age: 00073 YR