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

Model Number 995

Device Problems Degraded (1153); Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Endocarditis (1834); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Cardiac Tamponade (2226); Vascular Dissection (3160)

Event Date 06/26/2021

Event Type  Injury  

Manufacturer Narrative

Citation: zientara et al.Freestyle aortic root prosthesis in combination with aortic replacement and open anastomosis: a retrospect ive 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.

Manufacturer Narrative

Correction to codes in h6.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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
• MDR Report Key: 12334105
• MDR Text Key: 267052042
• Report Number: 2025587-2021-02577
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• 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
• Date Manufacturer Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR