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

Model Number 305_MOSAIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Congestive Heart Failure (1783); Non specific EKG/ECG Changes (1817); Unspecified Infection (1930); Myocardial Infarction (1969); Regurgitation (2259); Blood Loss (2597); Thromboembolism (2654)

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

Citation: y.Okamoto et al."early and late outcomes of aortic valve replacement using bioprosthetic versus mechanical valve in elderly patients: a propensity analysis" doi: 10.1111/jocs.12719 (j card surg 2016;31:195¿202) 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.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 regarding early and late outcomes of aortic valve replacement using bioprosthetic versus mechanical valve in elderly patients: a propensity analysis.All data were collected from a single center between (b)(6) 2014.The study population included 277 patients (predominantly female, mean age 80 years), 24 of which were implanted with medtronic ats mechanical valves and 36 were implanted with medtronic mosaic tissue valves (serial numbers not provided).Among all patients 14 deaths occurred.Multiple manufacturers were noted in the literature; based on the available information, none of the deaths were attributed to medtronic product.Among all patients adverse events included: cardiac arhythmias (atrioventricular block, ventricular fibrillation), re-operation for bleeding, stroke, infection, congestive heart failure, myocardial infarction, angina, minor paravalvular leak, thromboembolism.Based on the available information, these adverse events may have been attributed to medtronic product.

• 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: 6848633
• MDR Text Key: 85134856
• Report Number: 2025587-2017-01554
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 305_MOSAIC
• Device Catalogue Number: 305_MOSAIC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 80 YR