MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 995

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Myocardial Infarction (1969); Sepsis (2067)

Event Date 07/28/2021

Event Type  Injury  

Event Description

Medtronic received information via literature regarding the analysis of computed tomography angiography (cta) in aortic root replacement using a freestyle aortic root.All data were collected from a single center between 2005 and 2020.The study population included 32 patients (predominantly male, mean age 65 years), 10 of which had a post implant cta performed.Unique device identifier numbers were not provided.Among all patients, adverse events included: atrial fibrillation (afib), permanent pacemaker implant, cerebral vascular accident (cva), myocardial infarction (mi), bleeding complications treated with re-sternotomy, hemodynamic support (extracorporeal membrane oxygenation (ecmo) or intra-aortic balloon pump), sepsis and infection.Based on the available information a medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: osswald a, zubarevich a, rad aa, vardanyan r, zhigalov k, wendt d, schmack b, mashhour a, ruhparwar a, weymann a.Geometric changes in aortic root replacement using freestyle prosthesis.J cardiothorac surg.2021 jul 28;16(1):204.Doi: 10.1186/s13019-021 -01583-y.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.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 12836023
• MDR Text Key: 280953896
• Report Number: 2025587-2021-03483
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 995
• Device Catalogue Number: 995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2021
• 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): Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male