MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHETER PULMONARY VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number PB 10

Device Problems Gradient Increase (1270); Perivalvular Leak (1457); Incomplete Coaptation (2507)

Patient Problems Fistula (1862); Hematoma (1884); Hemothorax (1896); Insufficiency, Valvular (1926); Mitral Regurgitation (1964); Blood Loss (2597); Vascular Dissection (3160)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

Citation: joseph ta et al.Long-term outcomes of melody valve-in-valve implantation for bioprosthetic mitral valve dysfunction.Catheter cardiovasc interv.2019 may 1;93(6):1087-1094.Doi: 10.1002/ccd.27988.Epub 2018 nov 20.Earliest date of publish used for event date.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.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the long-term outcomes in patients with degenerated mitral bioprosthetic valves who were treated with transcatheter valve-in-valve implantation using the melody valve.All data were retrospectively collected from a single center between july 2011 and october 2013.The study population included 13 patients and was predominantly female with a mean age of 75 years.Of those, 3 were previously implanted with medtronic surgical valves in the mitral position: hancock (1) and mosaic (2).All patients underwent valve-in-valve implantation with a 22 mm medtronic melody transcatheter valve.No serial number were provided.Among all patients, 6 deaths occurred during follow-up.The reported causes of death were: septic shock and pneumonia (1), lymphoma (1), possible sudden cardiac death (1), and unknown causes (3).Based on the available information, medtronic product was not directly associated with the deaths.For the hancock patient (patient 3), adverse events included: mitral regurgitation that required valve-in-valve implantation 10 years after the hancock valve was implanted.Based on the available information, medtronic product was directly associated with the adverse event.For the mosaic patients, adverse events included: mitral regurgitation that required valve-in-valve implantation 4 years after the mosaic valve was implanted (patient 9), and mitral stenosis that required valve-in-valve implantation 8 years after the mosaic valve was implanted (patient 12).Based on the available information, medtronic product was directly associated with the adverse events.Adverse events observed after melody valve-in-valve implantation: severe mitral regurgitation caused by a loss of leaflet coaptation that required a repeat transcatheter valve-in-valve procedure (4.4 years after initial valve-in-valve), right iliac artery dissection with retroperitoneal bleeding that required surgical repair, thigh hematoma that required endovascular therapy, hemothorax that required chest tube drainage and blood transfusion, arterio-venous fistula, mild-moderate-severe mitral regurgitation, trace paravalvular leak, and increased mean transvalvular gradients.Based on the available information, medtronic product was directly associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MELODY TRANSCATHETER PULMONARY VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• 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: 9511386
• MDR Text Key: 187044792
• Report Number: 2025587-2019-03867
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PB 10
• Device Catalogue Number: PB 10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2019
• 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: 75 YR