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 Valve Stenosis (1717); Endocarditis (1834); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Transient Ischemic Attack (2109); Pericardial Effusion (3271); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

Citation: ezelsoy et al.Long term outcomes of freestyle stentless aortic bioprosthesis: a single center experience.Heart surg forum.(b)(6) 2020 10;23(1):e034-e038.Doi: 10.1532/hsf.2661.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 long-term clinical results after freestyle stentless aortic root bioprosthesis replacement.All data were collected from a single center between january 2003 and december 2008.The study population included 77 patients (predominantly male, mean age 68.7 years), all of which were implanted with a medtronic freestyle stentless aortic bioprosthetic valve (unique device identifier numbers not provided).Among all patients, there were 2 in-hospital deaths and 14 late deaths during the follow-up period (median of 11.2 years).Four of the late deaths were deemed valve-related and were attributed to endocarditis (n=2), thromboembolism (n=1) , and congestive heart failure (n=1).No further details were provided on these four deaths.Based on the available information medtronic product was directly associated with the four deaths.Among all patients, adverse events included: transient ischemic attack (n=4), moderate pleural effusion (n=2), superficial wound infection(n=2), bleeding (n=3) requiring surgical intervention, structural valve deterioration (n=3) with stenosis or regurgitation requiring a valve-in-valve procedure, and endocarditis (n=1) requiring reoperation to replace the aortic root.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.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12184914
• MDR Text Key: 262156958
• Report Number: 2025587-2021-02227
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 07/16/2021

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?: 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
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 07/16/2021
• 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; Life Threatening; Required Intervention
• Patient Age: 69 YR