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

Model Number 995

Device Problems Inadequacy of Device Shape and/or Size (1583); Structural Problem (2506)

Patient Problems Abscess (1690); Aortic Insufficiency (1715); Aortic Valve Stenosis (1717); Atrial Fibrillation (1729); Calcium Deposits/Calcification (1758); Endocarditis (1834); Unspecified Infection (1930); Cardiac Tamponade (2226); Blood Loss (2597); Complete Heart Block (2627)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

Citation: yang b.Aortic valve reoperation after stentless bioprosthesis: short- and long-term outcomes.Ann thorac surg.2018 aug; 106 (2): 521-525.Doi: 10.1016/j.Athoracsur.2018.02.073.Epub 2018 apr 3.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding short- and long-term outcomes after aortic valve reoperation after stentless bioprosthesis.All data were collected from a single center between 1997 and 2017.The study population included 143 patients (predominantly female, mean age 59 years), all of them were initially implanted with medtronic freestyle bioprosthesis.No serial numbers were provided.Approximately, 9 years post-implant the freestyle valve was replaced with freestyle stentlesss valve in 70 patients due to aortic stenosis, patient-prosthesis mismatch, aortic insufficiency, infective endocarditis with abscess ans structural valve deterioration (svd).Among all patients, 30-day and in-hospital mortality was 1% and 2%, respectively.Multiple manufacturers were noted in the literature.Based on the available information, medtronic product did not cause or contribute these deaths.Among all patients, adverse events included: aortic stenosis, patient-prosthesis mismatch, aortic insufficiency, infective endocarditis with abscess, infection, bleeding, tamponade, atrial fibrillation, complete heart block (chb), permanent pacemaker implantation and structural valve deterioration (svd) including calcification, leaflet fracture.Based on the available information a direct correlation could not be made between medtronic product and the observed 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: 8129268
• MDR Text Key: 129199491
• Report Number: 2025587-2018-03289
• 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: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• 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: 11/12/2018
• 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: 59 YR