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

Model Number 30519

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Unspecified Infection (1930); Blood Loss (2597)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

Citation: harky a et al.Stented versus stentless aortic valve replacement in patients with small aortic root: a systematic review and meta-analysis.Innovations (phila).2018 nov/dec;13(6):404-416.Doi: 10.1097/imi.0000000000000569.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.(b)(4).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 outcomes of stented versus stentless aortic valve replacement in patients with a small aortic root.All data were collected from a meta-analysis review of 7 studies published between 1999 and 2016.The study population included 965 patients and was predominantly female with a mean age of 74 years.An unspecified proportion of these patients were implanted with medtronic freestyle or mosaic bioprosthetic valves.No serial numbers were provided.Among all patients, 48 in-hospital and 57 one-year post-operative deaths were observed, respectively.Multiple manufacturers bioprosthetic valves were involved in the study and no further details about the deaths were provided.Based on the available information, medtronic product was not directly associated with the deaths.Among all patients, post-operative adverse events included: reoperation for bleeding, stroke, need for permanent pacemaker implantation, unspecified cardiac complications, atrial fibrillation, sternal wound infection, 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: 9628907
• MDR Text Key: 190328422
• Report Number: 2025587-2020-00279
• 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: Physician
• Type of Report: Initial
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• 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: 01/14/2020
• 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: 74 YR