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); Endocarditis (1834); Myocardial Infarction (1969); Post Operative Wound Infection (2446); Low Cardiac Output (2501); Blood Loss (2597); Complete Heart Block (2627); Pericardial Effusion (3271)

Event Date 12/06/2019

Event Type  Injury  

Manufacturer Narrative

Citation: mehdiani a et al.Mid-term single-centre outcomes of biointegral compared to freestyle aortic conduit implantation.J card iovasc surg (torino).2019 dec 6.Doi: 10.23736/s0021-9509.19.11098-1.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 comparison of the mid-term clinical and hemodynamic outcomes in patients who underwent full aortic root replacement with the biointegral composite biological valve or the stentless freestyle bioprosthesis.All data were prospectively collected from a single center between february 2013 and july 2017.The study population included 267 patients and was predominantly male with a mean age of 67 years and a mean weight of 74 kg.Of those, 65 were implanted with medtronic freestyle bioprosthetic valves.No serial numbers were provided.Among all freestyle patients, 27 deaths occurred within a mean follow-up period of 31 months.No further details were provided.Based on the available information, medtronic product was not directly associated with the deaths.Among all freestyle patients, intra-operative and post-operative adverse events included: permanent pacemaker implantation due to co mplete/permanent atrioventricular block, reoperation due to valve-related causes, reoperation due to unspecified causes, coronary artery bypass grafting due to coronary ostial misplacement, extracorporeal membrane oxygenation or intra-aortic balloon pump support, stroke, major bleeding, tracheostomy, pericardial effusion, new-onset atrial fibrillation, wound infection, myocardial infarction, valve-related endocarditis, and decreased ejection fraction.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: 9785745
• MDR Text Key: 193015954
• Report Number: 2025587-2020-00669
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• 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: 02/11/2020
• 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: 67 YR
• Patient Weight: 74