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

Model Number 995

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Unspecified Infection (1930); Low Cardiac Output (2501)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

Citation: easo j et al.Use of the medtronic freestyle for aortic valve infection: a retrospective propensity score matched analysis.J card surg.2019 oct;34(10):957-964.Doi: 10.1111/jocs.14176.Epub 2019 aug 2.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 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 the use of medtronic freestyle valve in the surgical treatment of native aortic and prosthetic valve endocarditis.All data were retrospectively collected from a single between january 1999 and september 2017.The study population included 430 patients and was predominantly male with a mean age of 63 years.Of those, 76 were implanted with medtronic freestyle bioprosthetic valves.No serial numbers were provided.Among all freestyle patients, 9 in-hospital deaths were observed.No further details were provided.Based on the available information, medtronic product was not directly associated with the deaths.Among all freestyle patients, adverse events included: endocarditis that required reoperation and valve replacement (duration from valve implant to onset of endocarditis was not reported), recurrent infection that required reoperation and valve replacement, post-operative permanent pacemaker implantation, post-operative need for extracorporeal membrane oxygenation or intra-aortic balloon pump support, stroke, rethoracotomy, and low cardiac output syndrome.Based on the available information, medtronic product was associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Corrected data: b5.Desc evt problem - of those, 22 were previously implanted with medtronic freestyle valves that were later replaced with a new freestyle valve or a non-medtronic valve product (mechanical valve, tissue valve, or homograft/stentless bioroot).In addition, 54 of the 430 patients underwent full aortic root replacement with the freestyle.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.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 9763777
• MDR Text Key: 181985549
• Report Number: 2025587-2020-00608
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• 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: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR