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

Model Number 30519

Device Problems Gradient Increase (1270); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Atrial Fibrillation (1729); Endocarditis (1834); Myocardial Infarction (1969)

Event Date 11/17/2018

Event Type  Injury  

Manufacturer Narrative

Citation: braathen b et al.Trifecta has lower gradient and less prosthesis-patient mismatch than mosaic ultra in the aortic position: a prospective randomized study.J thorac cardiovasc surg.2019 oct;158(4):1032-1039.Doi: 10.1016/j.Jtcvs.2018.11.020.Epub 2018 nov 17.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.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a comparison of the hemodynamic profiles between the trifecta and mosaic ultra bioprosthetic surgical valves.All data were collected from a single center between september 2012 and november 2014.The study population included 90 patients and was predominantly male with a mean age of 77 years.Of those, 38 were implanted with medtronic mosaic ultra valves in the aortic position.No serial numbers were provided.Among all patients, 2 deaths occurred due to: cerebral stroke (1) and lung infection with renal failure (1).The type of valve (trifecta or mosaic ultra) that was used to treat these 2 patients was not reported.Based on the available information, medtronic product was not directly associated with the deaths.Among all patients, adverse events included: reoperation due to endocarditis, myocardial infarction, post-operative atrial fibrillation, high transvalvular gradients, and patient-prosthesis mismatch.Based on the available information, medtronic product may have been associated with the adverse events.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: 9432009
• MDR Text Key: 185009045
• Report Number: 2025587-2019-03688
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 30519
• Device Catalogue Number: 30519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2019
• 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: 77 YR