MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; TIMER, CLOT, AUTOMATED

Model Number 30519

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

Patient Problems Aortic Valve Stenosis (1717); Congestive Heart Failure (1783)

Event Date 02/27/2019

Event Type  Injury  

Manufacturer Narrative

Citation: saxon j.Complications of bioprosthetic valve fracture as an adjunct to valve-in-valve tavr.Structural heart.27 feb 2019; 3:2, 92-99, doi: 10.1080/24748706.2019.1578446.Published online: 27 feb 2019.Earliest date of publication 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 the use of and complications associated with bioprosthetic valve fracturing (bvf) to facilitate valve-in-valve transcatheter aortic valve replacement (viv tavr).All data were collected from case reports.The study population included 8 patients (predominantly female, mean age 76 years), 2 of which were implanted with medtronic mosaic valves (no serial numbers provided) and 6 received corevalve evolut r valves during viv tavr (no serial numbers provided).Among all mosaic valve patients, adverse events included: diastolic heart failure and aortic stenosis.Based on the available information medtronic product was directly associated with the adverse events.

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: TIMER, CLOT, AUTOMATED
• 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: 8584598
• MDR Text Key: 144244578
• Report Number: 2025587-2019-01478
• Device Sequence Number: 1
• Product Code: GKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• 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: 04/09/2019
• 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): Life Threatening; Required Intervention
• Patient Age: 76 YR