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); Pulmonary Valve Stenosis (2024); Obstruction/Occlusion (2422); Pseudoaneurysm (2605); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 01/26/2013

Event Type  Injury  

Manufacturer Narrative

Citation: poynter ja, et al.Association of pulmonary conduit type and size with durability in infants and young children.Ann thorac surg.2013 nov;96(5):1695-701; discussion 1701-2.Doi: 10.1016/j.Athoracsur.2013.05.074.Epub 2013 aug 22.Presented at the forty-ninth annual meeting of the society of thoracic surgeons, los angeles, ca, jan 26¿30, 2013.Earliest date of presentation 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 surgeon-modifiable factors that optimize conduit durability in children less than 2 years of age at initial right ventricle to pulmonary artery (rv-pa) conduit insertion.All data was collected from 24 centers between january 2002 and august 2011.Of the 429 patients included in the study population (predominantly male; median age 1.7 months; mean weight 4.9 kg), an unspecified number of patients underwent rv-pa conduit implantation with a medtronic device: contegra valved conduit or freestyle bioprosthesis.No unique device identifier numbers were provided.The authors stated the median follow-up period was 6 years (range of 17 days to 11.7 years).Among all patients, 22 deaths had occurred prior to last follow-up (between july and august 2011).No statement was made suggesting a causal or contributory relationship between medtronic product and the deaths.Among all patients, adverse events included: conduit explantation with or without replacement.Reasons for explantation consisted of conduit obstruction/stenosis, regurgitation, pseudoaneurysm, and unknown.Additional procedures and/or interventions performed throughout the duration of the study: surgical conduit repair, catheter-based conduit ballooning/stenting, complete or partial pulmonary artery unifocalization, right or bilateral pulmonary arterioplasty, atrial and/or ventricular septal defect repair/closure, pulmonary artery banding, aortic arch repair, pacemaker implantation, coarctation repair, chest reopening, extracorporeal membrane oxygenation-related, delayed sternal closure, branch pulmonary artery angioplasty with or without stent, right and/or left pulmonary artery stent, right and/or left pulmonary artery dilatation, and coil closure of collaterals.Medtronic product may have been 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: 12624233
• MDR Text Key: 276163455
• Report Number: 2025587-2021-03029
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• 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: 10/05/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 2 MO
• Patient Weight: 5