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 Endocarditis (1834); Hemorrhage/Bleeding (1888); Rupture (2208); Fibrosis (3167); Pericardial Effusion (3271); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 09/11/2012

Event Type  Injury  

Manufacturer Narrative

Citation: weimar t et al.Strategies for biological heart valve replacement: stentless xenografts fail to evolve into an alternative pulmonary valve substitute in a ross procedure.Biotechnol j.2013 mar;8(3):345-51.Doi: 10.1002/biot.201200288.Article online 11 sep 2012.Earliest date of publish used for date of event.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 from a literature article regarding the early and mid-term outcomes of stentless bioprostheses in comparison to pulmonary homografts as the pulmonary valve substitute in the ross procedure.All data was retrospectively collected from a single center between 2004 and 2008.The overall study population included 139 patients and was divided into two groups: homograft group (106 patients) and stentless group (33 patients).In the stentless group, all patients underwent right ventricular outflow tract reconstruction with medtronic freestyle bioprosthetic valves (predominantly male, median age 43 years).No serial numbers were provided.Among all 139 patients, the overall mortality at one-year follow-up was 1.4% (2 patients).The causes of death included: cardiac arrest that occurred nine days after discharge and medication-induced bradycardia was suspected (1), and non-cardiovascular causes (1).The type of product (pulmonary homograft or stentless freestyle valve) implanted in these two patients was not reported.Based on the available information, medtronic product was not directly associated with the deaths.Among all 139 patients, adverse events included: reoperation due to double-valve endocarditis (implant duration unknown).Based on the available information, medtronic product may have been associated with the adverse event.Among all patients in the stentless group, adverse events included: reoperation for bleeding or pericardial effusion; valve explanted and replaced within two years post-implant due to fibrous tissue ingrowth at the proximal anastomosis causing elevated gradients (more than 30 mmhg); and mild to severe pulmonary insufficiency.In addition, it was mentioned that 14 freestyle valves from a separate study were explanted due to non-infective aortic wall rupture.Based on the available information, medtronic product was 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11121414
• MDR Text Key: 226768934
• Report Number: 2025587-2021-00035
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• 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: 12/11/2020
• 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): Life Threatening; Required Intervention
• Patient Age: 43 YR