MAUDE Adverse Event Report: HEART VALVES SANTA ANA MELODY TRANSCATHETER PULMONARY VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI

Model Number PB 10

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiovascular Insufficiency (4445); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2021

Event Type  Injury  

Manufacturer Narrative

Citation: takajo et al.Impact of patient prosthesis mismatch on the outcome of transcatheter pulmonic valve implantation.Am j cardiol.2021 jul 15;151:93-99.Doi: 10.1016/j.Amjcard.2021.04.022.Epub 2021 may 27.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 impact of patient prosthesis mismatch on the outcome of transcatheter aortic valve replacement (tavr).All data were collected from a single center between 2010 and 2020.The study population included 101 patients (predominantly male, mean age 21.3 years, mean weight 62 kg).All patients were implanted with a medtronic melody pulmonary bioprosthetic valve (unique device identifier numbers not provided).Among all patients, adverse events included: patient-prosthesis mismatch (ppm), residual right ventricular outflow tract (rvot) gradients =15 mmhg, and reintervention to treat these observations.Based on the available information medtronic product was associated with 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 DELI
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12807801
• MDR Text Key: 281746456
• Report Number: 2025587-2021-03440
• 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: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• 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: 10/14/2021
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 21 YR
• Patient Weight: 62 KG