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

Model Number 995

Device Problems Perivalvular Leak (1457); Structural Problem (2506)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Endocarditis (1834); Thrombus (2101); Cardiac Perforation (2513); Blood Loss (2597)

Event Date 10/01/1999

Event Type  Injury  

Manufacturer Narrative

Citation: billie s.Fyfe.Pathological analysis of nonstented freestyle aortic root bioprostheses treated with amino oleic acid.Seminars in thoracic and cardiovascular surgery.1999 october; 11(4 suppl 1): 151-156.Doi: not available 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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature review regarding pathological analysis of the freestyle aortic root bioprosthesis treated with amino oleic acid.All data were collected from multiple centers.The study population included 1,100 patients, 67 patients of which had the freestyle device explanted.The study population was predominantely male.Serial numbers were not provided.Among all patients adverse events included: blood loss, iatrogenic valve damage, endocarditis, paravalvular leak (pvl), stenosis, regurgitation, calcification, fistula, cusp tear/cusp separation, thrombus treated with valve explant.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: 7470570
• MDR Text Key: 106831601
• Report Number: 2025587-2018-01013
• 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: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• 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: 04/05/2018
• 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