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

Model Number 305_MOSAIC

Device Problems Calcified (1077); Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Structural Problem (2506); Torn Material (3024)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Endocarditis (1834); Hemolytic Anemia (2279)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

Citation: jessica webb.A comparison of early redo surgery rates in mosaic porcine and perimount bovine pericardial valves.European journal of cardio-thoracic surgery.(b)(6) 2018; 0, 1-5.Doi: 10.1093/ejcts/ezy113 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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature review regarding redo surgery rates of patients with mosaic and perimount valves.All data were collected from a single center between 2000 and 2008.The study population included 1018 patients, 216 of which were implanted with a mosaic valve.Serial numbers were not provided.The mosaic study population was predominantly male; mean age 75 years.Among all patients adverse events included: aortic regurgitation, stenosis, endocarditis, structural (calcification, leaflet tear or stent creep) and non structural valve deterioration (stenosis or regurgitation or haemolysis, e.G.Pannus, patient prosthesis mismatch and paraprosthetic leak) treated with redo surgery.Based on the available information, these events may have been attributed to a medtronic product.However as multiple manufacturers were noted in the literature, a direct correlation could not be made between the observed adverse events and the medtronic product.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, REPLACEMENT
• 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: 7464722
• MDR Text Key: 106617736
• Report Number: 2025587-2018-00987
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2018
• 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: 75 YR