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 Non specific EKG/ECG Changes (1817); Ventricle, Abnormality Of (2078); Vascular System (Circulation), Impaired (2572)

Event Date 11/10/2005

Event Type  Injury  

Manufacturer Narrative

Citation: kincaid eh et al.Coronary insufficiency after stentless aortic root replacement: risk factors and solution.Annals of thoracic surgery.2007; 83:964-968.Doi: 10.1016/j.Athoracsur.2006.09.021.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 a retrospective analysis of the incidence of coronary insufficiency following aortic root replacements in adult patients.All data were collected from a single center between 1993 and 2005.The study population included 503 patients (predominantly male, mean age 69 years), 477 of which were implanted with medtronic freestyle valves (no serial numbers provided).Among all patients, 30 patients died either in the hospital or within 30 days of the procedure.One of these patients was from the coronary insufficiency patient population.No further details were provided about the deaths, and multiple manufacturers were mentioned in the literature.Based on the available information medtronic product was not directly associated with the deaths.Among all medtronic freestyle patients, adverse events included: coronary insufficiency, ventricular dilation, and ventricular arrhythmias.It was reported that the cases of coronary insufficiency were treated by ¿resuming cardiopulmonary bypass and aortocoronary bypass grafting of the right main coronary artery with reversed saphenous vein and without additional aortic cross clamping.¿ based on the available information medtronic product was directly 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: 9533521
• MDR Text Key: 185712766
• Report Number: 2025587-2019-03925
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: 12/03/2019
• 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