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 Atrial Fibrillation (1729); Stroke/CVA (1770); Congestive Heart Failure (1783); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Unspecified Infection (1930); Sepsis (2067); Blood Loss (2597)

Event Date 11/23/2018

Event Type  Injury  

Manufacturer Narrative

Citation: bianco v et al.Aortic root replacement with stentless xenografts in patients with aortic stenosis.J thorac cardiovasc surg.2019 oct;158(4):1021-1027.Doi: 10.1016/j.Jtcvs.2018.11.028.Epub 2018 nov 23.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 an evaluation of the outcomes in patients with aortic stenosis who underwent aortic root replacement using the freestyle bioprosthesis.All data were retrospectively collected from a single center between 2011 and 2017.The study population included 294 patients (predominantly male; mean age 68 years; 93% white).Of those, all were implanted with medtronic freestyle bioprosthetic valves.No serial numbers were provided.Among all patients, the mortality rate within 30 days, 1 year, and 5 years post implant were 7.1%, 13.9%, and 23.7%, respectively.Based on the available information, medtronic product was not directly associated with the deaths.Among all patients, adverse events included: new permanent pacemaker implantation, stroke, deep sternal wound infection, post-operative sepsis, surgical re-exploration due to mediastinal bleeding, reoperation due to endocarditis, bleeding requiring blood transfusion, new-onset atrial fibrillation, and hospital re-admission for congestive heart failure.Based on the available information, medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• 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: 9307157
• MDR Text Key: 173931158
• Report Number: 2025587-2019-03445
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2019
• 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): Required Intervention
• Patient Age: 68 YR