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 Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Blood Loss (2597)

Event Date 08/29/2012

Event Type  Injury  

Manufacturer Narrative

Citation: finch, jonathan.Failing stentless aortic valves: redo aortic root replacement or valve in a valve? european journal of cardio-thoracic surgery.(2012).43: 495¿504 doi 10.1093/ejcts/ezs335 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.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature review regarding redo aortic root replacement versus valve-in-valve treatment for failed stentless aortic valves.All data were collected from a single center between 2000 and 2010.The study population included a total of 101 patients.Sixty-five patients (predominantly male; average age 61.5 ± 14.2 years) underwent a valve-in-valve replacement (group a).Forty-five patients (predominantly male; average age 61.9 ± 12.1 years), underwent a redo root replacement (group b).Group b contained one patient who had been implanted with a medtronic freestyle aortic root (serial numbers not provided).During the redo procedure medtronic mosaic, mosaic ultra and freestyle valve were implanted.Among all patients implanted with a freestyle adverse events included: electrocardiogram (ecg) changes treated with a permanent pacemaker, cerebral vascular accident (cva), bleeding treated with re-sternotomy, aortic regurgitation and stenosis.Based on the available information, these events may have been attributed to a medtronic product, however a direct correlation could not be made between the observed adverse events and medtronic product.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: 6744194
• MDR Text Key: 81052192
• Report Number: 2025587-2017-01244
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• 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: 07/05/2017
• 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: 62 YR