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

Model Number PB 10

Device Problem Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/28/2019

Event Type  Injury  

Manufacturer Narrative

Citation: yoon sh; et al.Predictors of left ventricular outflow tract obstruction after transcatheter mitral valve replacement.Jacc cardiovasc interv., 2019 jan 28;12(2):182-193.Pmid: 30678797.Doi: 10.1016/j.Jcin.2018.12.001.Earliest date of publication used for date of event.Medtronic products referenced: melody (pma# p140017, product code: npv).Earliest approved product used for product code and pma#.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 predictors of left ventricular outflow tract (lvot) obstruction after transcatheter mitral valve replacement (tmvr).All data were collected from multiple centers between february 2009 and january 2018.The study population included 194 patients who underwent pre-procedural computed tomography (ct) scans and echocardiographic studies for tmvr planning.The patients were predominantly female with a mean age of 76 years.Multiple manufacturer¿s devices were implanted in the study population.Among all patients, one patient underwent transcatheter valve-in-valve (viv) implantation using a medtronic melody bioprosthetic valve (unique device identifier number not provided).It was noted that no procedural deaths occurred in the patients who underwent transcatheter viv tmvr.Among all viv tmvr patients, adverse events included: lvot obstruction, requiringmedical management and ventricular septal wall alcohol ablation.Based on the available information medtronic product may have been associated with the adverse event.

• Brand Name: MELODY TRANSCATHETER PULMONARY VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI
• 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: 14526939
• MDR Text Key: 293490627
• Report Number: 2025587-2022-01503
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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: 05/02/2022
• 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: 76 YR
• Patient Sex: Female