MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC BIOPROSTHETIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 310

Device Problems Perivalvular Leak (1457); Patient Device Interaction Problem (4001); Central Regurgitation (4068)

Patient Problems Pseudoaneurysm (2605); Valvular Insufficiency/ Regurgitation (4449); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 01/05/2022

Event Type  Injury  

Event Description

Literature was reviewed regarding a 44-year-old female patient with a history of repaired tetralogy of fallot (tof) and three subsequent right ventricular outflow tract (rvot) procedures.Four years prior, the patient underwent a fourth sternotomy with implant of a medtronic 31 mm mosaic bioprosthetic valve in the pulmonary position along with a non-medtronic extracellular matrix (ecm) patch of the rvot.More recently the patient presented with severe pulmonary insufficiency.Echocardiography showed severe paravalvular regurgitation.Computed tomography showed patch dehiscence from the anterior sewing ring and associated pseudoaneurysm.Preoperative blood cultures were negative.Subsequently, the patient underwent a fifth-time sternotomy under cardiopulmonary bypass in which the mosiac valve and ecm patch were explanted and successfully replaced by a non-medtronic bioprosthetic valve and bovine pericardial patch of the rvot.All infectious testing of operative specimens was negative.The patient was discharged home four days post-operative.Follow-up imaging confirmed a well-seated normal functioning bioprosthetic valve.No further information pertaining to medtronic products was noted.

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review and remediation per d00955245.Citation: burke et al.Title: is porcine small intestinal submucosal extracellular matrix (ecm) a suitable material for right ventricular outflow tract reconstruction in association with pulmonary valve replacement? world j pediatr congenit heart surg.2022 jul;1 3(4):518-521.Doi: 10.1177/21501351211069559.Earliest date of publication 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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

A supplemental report is being submitted for correction to h10 of the previous report to reference the capa #.This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) related to capa pr 564122.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: MOSAIC BIOPROSTHETIC VALVE
• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18234558
• MDR Text Key: 329314999
• Report Number: 2025587-2023-04978
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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: 310
• Device Catalogue Number: 310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 12/06/2023
• 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; Hospitalization
• Patient Age: 44 YR
• Patient Sex: Female