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

Model Number PB 10

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Regurgitation, Valvular (2335); No Information (3190)

Event Date 06/21/2019

Event Type  Injury  

Manufacturer Narrative

Citation: haas n.The standing of percutaneous pulmonary valve implantation compared to surgery in a non-preselected cohort with dys functional right ventricular outflow tract ¿ reasons for failure and contraindications.J cardiol.2019 sep;74(3):217-222.Doi: 10.1016/j.Jjcc.2019.03.021.Epub 2019 jun 21.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature comparing percutaneous pulmonary valve implantation (ppvi) versus surgical valve implantation for patients with dysfunctional right ventricular outflow tracts (rvot).All data were retrospectively collected from a single center between january 1, 2010 and december 31, 2015.The study population included 246 patients who underwent pulmonary valve implantation (demographic data not provided), 106 of which were implanted with medtronic contegra bioprosthetic valved conduits, 29 with medtronic melody bioprosthetic valves, and 5 with medtronic hancock ii bioprosthetic valves.No serial numbers were provided.Among all patients, adverse events related to bioprosthetic valves or valved-conduits included: valve dislocations, insufficient reg urgitation, and surgical intervention.Based on the available information medtronic product may have been associated with these 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: 9521995
• MDR Text Key: 173298494
• Report Number: 2025587-2019-03890
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• 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: 12/02/2019
• 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): Congenital Anomaly; Required Intervention