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

Model Number 30519

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

Patient Problems Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 05/15/2021

Event Type  Injury  

Manufacturer Narrative

Citation:brinkmann c, et al.Bioprosthetic valve fracture: predictors of outcome and follow-up.Results from a multicenter study.Catheter cardiovasc interv.2021 may 15.Doi: 10.1002/ccd.29755.Earliest date of publish used for date of event.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 outcomes of bioprosthetic valve fractures in patients undergoing a valve-in-valve transcatheter aortic valve (tav) implantation.The study population included 81 patients (predominantly female, mean age 76 years), 22 of whom had a previously implanted medtronic mosaic bioprosthetic surgical valve and 57 of whom were implanted with medtronic evolutr or evolutpro tav.No serial numbers were reported.Among all patients, one intra-operative death due to an iliac artery perforation occurred.The death was not attributed to a medtronic device.Among all patients with a previously implanted bioprosthetic surgical valve, adverse events included: stenosis, mild to severe regurgitation, patient-prosthesis mismatch (ppm), and increased gradient measurements.Based on the available information a medtronic product may have been associated with the adverse events.Among all patients implanted with a valve-in-valve transcatheter aortic valve, adverse events included: permanent pacemaker implant, increased gradient measurements, ventricular septal perforation, severe aortic regurgitation.Based on the available information a medtronic product may have been associated with the adverse events.No additional adverse patient effects were reported.

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: REPLACEMENT HEART-VALVE
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11999981
• MDR Text Key: 256245191
• Report Number: 2025587-2021-01892
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• 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: 05/26/2021
• 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: 76 YR
• Patient Weight: 74