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); Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969); Cardiac Tamponade (2226); Low Cardiac Output (2501); Blood Loss (2597)

Event Date 03/13/2019

Event Type  Injury  

Manufacturer Narrative

Citation: easo j et al.Hospital results of a single center database for stentless xenograft use in a full root technique in over 970 patients.Sci rep.2019; 9: 4371.Doi: 10.1038/s41598-019-40772-7.Published online 2019 mar 13.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 analysis of the hospital outcomes in patients who underwent aortic root replacement using a stentless bioroot xenograft.All data were retrospectively collected from a single center between november 1999 and march 2017.The study population included 971 patients and was predominantly male with a mean age of 69 years.All patients were implanted with medtronic freestyle bioprosthetic valves.No serial numbers were provided.Among all patients, the overall hospital mortality rate was 9.8% (95 patients).Of those, 10 patients died due to acute dissections and 3 died during re-operative procedures.Based on the available information, medtronic product may have been associated with these 13 deaths.Among all patients, post-operative adverse events included: stroke/permanent neurological impairment; bleeding that required surgical revision; permanent pacemaker implantation; need for extracorporeal membrane oxygenation, intra-aortic balloon pump support, or cardiopulmonary resuscitation; pericardial tamponade; need for reintubation or tracheotomy; atrial fibrillation; myocardial infarction; and low 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.

• 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: 9764549
• MDR Text Key: 181989833
• Report Number: 2025587-2020-00617
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/27/2020

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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2020
• 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: 69 YR