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 Aortic Valve Stenosis (1717); Stroke/CVA (1770); Foreign Body Reaction (1868); Myocardial Infarction (1969); Pseudoaneurysm (2605); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 05/12/2021

Event Type  Injury  

Manufacturer Narrative

Citation: dagnegård et al.Structural abnormalities after aortic root replacement with stentless xenograft.J thorac cardiovasc surg.2021 may 12;s0022-5223(21)00792-3.Doi: 10.1016/j.Jtcvs.2021.04.087.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.

Event Description

Medtronic received information via literature regarding structural abnormalities after aortic full root replacement with stentless x enografts.All data including clinical follow-up were collected from two centers between 1999 and 2017.The study population included 253 patients (predominantly male, mean age 70 years), all of which were implanted with a medtronic freestyle stentless bioprosthesis.No unique device identifier numbers were provided.Among all patients, 144 patients who died were excluded from the study analysis.Within the study population, there was a 4.1% all-cause mortality rate.The circumstances of the deaths were not disclosed, and no correlation was made between medtronic product and the deaths.Based on the available information medtronic product was not directly associated with the death(s).Among all patients, adverse events included: pseudoaneurysm, severe coronary ostial stenosis, severe leaflet thickening or reduced leaflet motion, severe aortic regurgitation, structural valve dysfunction, myocardial infarction (mi), and stroke.Many of these conditions required intervention as treatment with long hospital stays.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.

Event Description

Additional information received from the physician/author stated: 1) there was no conclusive data relating medtronic product or its function to the observed deaths or other adverse events, 2) no unique device identifier information was available, 3) explanted prostheses were discarded following evaluation and are therefore not available for return, and 4) the mean patient weight was 81.8 kg.

Manufacturer Narrative

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: 12014041
• MDR Text Key: 263572423
• Report Number: 2025587-2021-01917
• 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: 07/12/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 995
• Device Catalogue Number: 995
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 07/12/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 82