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

Model Number 995

Device Problems Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems Host-Tissue Reaction (1297); Congestive Heart Failure (1783); Pulmonary Valve Stenosis (2024)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Citation: dunne b et al.The freestyle valve as a right ventricle to pulmonary artery conduit: a systematic review and meta-analysis.Heart, lung and vessels.2015; 7(4): 304-310.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.

Event Description

Medtronic received information via literature regarding a meta-analysis of echocardiographic and clinical outcomes associated with an aortic root bioprosthesis in the pulmonary position for both ross and congenital surgery.All data were collected from clinical databases medline, pubmed, cochrane database, and (b)(6) scholar between (b)(6) 1980 to (b)(6) 2014.The study population included 311 patients (specific demographics not provided, reported as pediatric to adult age patients), all of which were implanted with a medtronic freestyle bioprosthetic valve (serial numbers not provided).Among all patients adverse events included: 311 structural valve dysfunction, 3 conduit compression, 2.3% heart failure, 7 stenosis due to pannus or stricture formation requiring intervention, and 2 valvular stenosis requiring intervention.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 6440440
• MDR Text Key: 71092882
• Report Number: 2025587-2017-00500
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 02/27/2017

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: 02/27/2017
• Initial Date FDA Received: 03/28/2017
• Supplement Dates Manufacturer Received: 02/27/2017
• Supplement Dates FDA Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: No
• 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