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

Model Number MDT-TISSUE VALVE

Device Problems Gradient Increase (1270); Patient Device Interaction Problem (4001); Central Regurgitation (4068)

Patient Problems Endocarditis (1834); Hemorrhage/Bleeding (1888); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 07/29/2022

Event Type  Injury  

Manufacturer Narrative

Citation: çekirdekçi et al.Infective endocarditis after transcatheter approach versus surgical pulmonary valve replacement: a meta-analysis.Turkish journal of thoracic and cardiovascular surgery.2022;30(3):472-483.Doi: 10.5606/tgkdc.Dergisi.2022.23506.Published online 2022 jul 29.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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Literature was reviewed regarding a meta-analysis on infective endocarditis after transcatheter and surgical pulmonary valve replace ment.  the study population included 4706 patients who were predominantly male with a mean age of 23 years.  multiple manufacturer¿s devices were implanted in the study population across 15 peer-reviewed articles; an undisclosed number of patients were implanted with a medtronic melody or harmony transcatheter valve or a hancock or contegra surgical valve.  deaths occurred in the study population; however, there was no statement establishing a causal or contributory relationship between medtronic product and the deaths.  among all patients adverse events included: moderate to severe pulmonary regurgitation, high peak gradients, bleeding or vascular complication, and infective endocarditis treated medically or surgically. no further information was provided pertaining to medtronic products.

• Brand Name: MEDTRONIC SURGICAL TISSUE 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19160533
• MDR Text Key: 340800504
• Report Number: 2025587-2024-02459
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDT-TISSUE VALVE
• Device Catalogue Number: MDT-TISSUE VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• 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: 23 YR
• Patient Sex: Male