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

Model Number PB 10

Device Problems Fracture (1260); Activation Failure (3270)

Patient Problems Cardiac Arrest (1762); Endocarditis (1834); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pleural Effusion (2010); Pseudoaneurysm (2605); Heart Block (4444); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 04/05/2020

Event Type  Injury  

Manufacturer Narrative

Citation: ribeiro et al.Transcatheter versus surgical pulmonary valve replacement: a systemic review and meta-analysis.Ann thorac surg.2020 nov;110(5):1751-1761.Doi: 10.1016/j.Athoracsur.2020.03.007.Epub 2020 apr 5.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 via literature regarding transcatheter versus surgical pulmonary valve replacement.All data were collected from a meta-analysis review of 18 published articles found between article inception to january 2019.The study population included 6,071 patients (predominantly male, mean age 21.9 years), whom were implanted with either a non-medtronic or a medtronic melody tpv (no unique device identifier numbers provided).Based on the available information, a death occurred within a tpv group in three of the 18 articles included in the meta-analysis review.Multiple manufacturer¿s devices were implanted in the study population.None of the deaths were directly associated with medtronic product.Based on the available information medtronic product was not directly associated with the death(s).Among all tpv patients, adverse events included: severe pulmonary regurgitation, endocarditis, high transvalvular gradients, pseudo aneurysm, arteriovenous fistula, stent fracture, transcatheter pulmonary valve deployment issue, hemorrhage, hematoma, transient atrioventricular conduction block, conduit perforation, hemothorax/pneumothorax/pleural effusion requiring chest tube, cardiopulmonary arrest with crushed melody valve from chest compressions, infection/fever, and repeat intervention.Based on the available information medtronic product was directly associated with some the adverse event(s).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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11413905
• MDR Text Key: 234712764
• Report Number: 2025587-2021-00754
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 02/17/2021
• 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): Life Threatening; Required Intervention
• Patient Age: 22 YR