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

Model Number 30519

Device Problems Inadequacy of Device Shape and/or Size (1583); Obstruction of Flow (2423)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

Citation: akodad m et al.Hemodynamic performances and clinical outcomes in patients undergoing valve-in-valve versus native transcatheter aortic valve implantation.Am j cardiol.2019 jul 1;124(1):90-97.Doi: 10.1016/j.Amjcard.2019.04.009 (including supplementary material).Epub 2019 apr 18.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 the 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 performances and clinical outcomes in patients who underwent aortic valve-in-valve procedure versus transcatheter aortic valve implantation in patients with native aortic stenosis.All data were retrospectively collected from two centers between 2013 and 2017.The study population included 132 patients (predominantly female; mean age 83 years), 2 patients were previously implanted with medtronic mosaic surgical aortic valves and one was previously implanted with a medtronic 3f enable surgical aortic valve (no serial numbers provided).Among the mosaic and 3f enable patients, adverse events included: transcatheter aortic valve-in-valve implantation due to stenosis, regurgitation, combination of both, or patient-prosthesis mismatch.Onset of structural valve deterioration was noted to have occurred at a mean 9 years after surgical valve implant.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: 9349496
• MDR Text Key: 170791290
• Report Number: 2025587-2019-03531
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• 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: 11/15/2019
• 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: 83 YR