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 Vascular Dissection (3160); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 06/26/2021

Event Type  Death  

Manufacturer Narrative

Citation: zientara et al.Freestyle aortic root prosthesis in combination with aortic replacement and open anastomosis: a retrospective analysis.J cardiothorac surg.2021 jun 26;16(1):185.Doi: 10.1186/s13019-021-01562-3.Earliest date of publish used for date of event and date of death.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 freestyle aortic root prosthesis in combination with aortic replacement and open anastomosis.All data were collected retrospectively from a single center between september 2007 and march 2017.The study population included 278 patients (predominantly male, mean age 62 years), all of which were implanted with medtronic freestyle aortic root bioprosthesis (unique device identifier numbers not provided).The patients were divided into two groups for comparison: 119 in the open arch anastomosis (oa) group and 152 in the non-open arch anastomosis (non-oa) group.Among all patients, 16 total deaths occurred (8 from the oa and 8 from the non-oa groups).In the oa group, 4 of 8 in-hospital deaths occurred due to acute type a dissection.In longer term follow-up, one patient died four years after implant due to heart failure with noted moderate valvular regurgitation.Based on the available information medtronic product may have been associated with the death(s).Among all patients, adverse events included: stroke, bleeding requiring intervention, tamponade, myocardial infarction (mi), endocarditis requiring intervention, structural valve dysfunction (svd) causing ¿moderate to severe impairment¿, and dissection requiring intervention.Based on the available information medtronic product may have been associated with the adverse event(s).No additional adverse patient effects or product performance issues were reported.

• 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: 12334100
• MDR Text Key: 267017230
• Report Number: 2025587-2021-02576
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970031
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 08/17/2021
• 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): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR