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 Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Myocardial Infarction (1969); Heart Failure (2206); Low Cardiac Output (2501); Blood Loss (2597); Pseudoaneurysm (2605); Complete Heart Block (2627); Pericardial Effusion (3271)

Event Date 11/07/2007

Event Type  Injury  

Manufacturer Narrative

Citation: lemaire sa et al.Aortic root replacement with stentless porcine xenografts: early and late outcomes in 132 patients.Ann thorac surg.2009 feb;87(2):503-12; discussion 512-3.Doi: 10.1016/j.Athoracsur.2008.11.033.Presented at the fifty-fourth annual meeting of the southern thoracic surgical association, bonita springs, fl, nov 7¿10, 2007.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 a retrospective study into the early and late outcomes in patients who underwent aortic root replacement with stentless porcine xenografts.All data were collected from a single center between march 2001 and july 2007.The study population included 132 patients and was predominantly male with a mean age of 55 years.Of those, 54 were implanted with medtronic freestyle aortic root bioprostheses.No serial numbers were provided.Among all freestyle patients, 14 deaths occurred during follow-up (range of 39 days to 6.8 years).It was reported that 7 deaths were due to ventricular failure and 6 deaths were caused by left main coronary stenosis with myocardial infarction (1 case; noted to be unrelated to the valve), rupture of a pseudoaneurysm (1), sepsis (1), myocardial infarction (1), and pneumonia (1).Based on the available information, these combined 12 deaths were not associated with medtronic product.The remaining 2 deaths were deemed valve-related and were due to recurrent endocarditis with dehiscence of a prosthetic mitral valve (1) and endocarditis with root abscess (1).Based on the available information, medtronic product was directly associated with these 2 deaths.Among all patients, adverse events included: stroke, bleeding requiring reoperation, valve-related complication requiring reoperation, heart block requiring permanent pacemaker implantation, ventricular or atrial arrhythmia, cardiac failure, myocardial infarction, pericardial effusion requiring drainage, endocarditis, pseudoaneurysm, mild-moderate aortic stenosis, aortic regurgitation (noted to be ¿minimal¿), and reduced left ventricular ejection fraction post-implant.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

Additional information received from the physician/author confirmed the following details: medtronic product did cause or contribute to the 2 valve-related deaths.The mean patient weight.Updated data: added mean patient weight (193 lbs) the observed adverse events in the article have not been previously reported to medtronic.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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: 9410433
• MDR Text Key: 185247806
• Report Number: 2025587-2019-03661
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• 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: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 88