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

Model Number 995

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Insufficiency (1715); Aortic Valve Stenosis (1717); Arrhythmia (1721); Infarction, Cerebral (1771); Endocarditis (1834); Unspecified Infection (1930); Renal Failure (2041); Ventilator Dependent (2395); Blood Loss (2597)

Event Date 12/10/2016

Event Type  Injury  

Manufacturer Narrative

Citation: jiro esaki, md, phd.Clinical outcomes of the david v valve-sparing root replacement compared with bioprosthetic valve-con duits for aortic root aneurysms.Ann thorac surg, publish date 2017; volume 103(6): pages 1824-1832: doi 10.1016/j.Athoracsur.2016.09.055 the earliest date of publication was used for the event date for this literature article.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.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.

Event Description

Medtronic received information via literature regarding clinical outcomes of valve-sparing root replacement (vsrr) compared with those of conventional root replacement with the use of a bioprosthetic valve-conduits for aortic root aneurysms.This study compared the operative and midterm results.All data was collected from a single center between the years of 2002 to 2015.The study included 707 patients, predominantly male with a mean age of 53 years old.A total of 425 patient were implanted with a bioprosthetic valve-conduit of multiple manufacturers.A total of 111 of the 425 patients were implanted with a medtronic freestyle or mosaic device, serial numbers were not provided.Among all patients adverse events included: bleeding, prolonged ventilator, intra-aortic balloon pump placement, renal failure, transient ischemic attack (tia), stroke, permanent pacemaker implant, and deep sternal infection.Based on the available information, these events may have been attributed to a medtronic product.

• 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6712739
• MDR Text Key: 80008617
• Report Number: 2025587-2017-01173
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• 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
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention
• Patient Age: 53 YR