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

Model Number 995

Device Problem Gradient Increase (1270)

Patient Problems Insufficiency, Valvular (1926); Unspecified Infection (1930); Pulmonary Valve Stenosis (2024)

Event Date 12/01/2003

Event Type  Injury  

Manufacturer Narrative

Title: results with the freestyle porcine aortic root for right ventricular outflow tract reconstruction in children citation: ann thorac surg (2003) 76:1889 ¿95 (doi 10.1016/s0003-4975(03)01304-3) authors: kanter, kirk r.Et al.Earliest date of e-publish/publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it cannot be determined whether this event has been previously reported.

Event Description

Medtronic received information via literature review regarding the results of the use of freestyle porcine aortic root for right ven tricular outflow tract (rvot) repair in children.All data were collected from a single center between 1998 and 2002.The study population included 56 patients (mean age 11.8 years), 43 of which were implanted with medtronic freestyle aortic root (serial numbers not provided).Among all patients adverse events included: post-operative mediastinitis that was treated with a muscle flap closure.Endocarditis was also noted in a patient with a previously implanted homograft.It was reported that when the homograft was removed and replaced with the freestyle, the homograft was positive for candida.Subsequently, the patient developed endocarditis and was medically treated.The freestyle was replaced 3.5 years later due to stenosis.Other adverse events included 23 incidents of trivial to mild insufficiency and 4 incidents of moderate insufficiency and 1 incident of clinically significant increase gradient measurements.Multiple manufacturers were noted in the literature; based on the available information a direct correlation could not be made between the observed adverse events and medtronic product.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: 6430924
• MDR Text Key: 70737898
• Report Number: 2025587-2017-00463
• 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,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: 03/24/2017
• 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
• Patient Age: 12 YR