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

Model Number PB 10

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Great Vessel Perforation (2152); Obstruction/Occlusion (2422); Cardiovascular Insufficiency (4445)

Event Date 11/18/2021

Event Type  Injury  

Manufacturer Narrative

Citation: guyon, et al.Expanded use of the one-step technique for simultaneous landing zone stenting and placement of the melody transcatheter pulmonary valve.J invasive cardiol.2021 dec;33(12):e954-e959.Epub 2021 nov 18.Pmid: (b)(4).Earliest date of publish 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.Unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether this event has been previously reported.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding outcomes from using a new implant technique for transcatheter pulmonary valve implantation (tpvi).All data were collected from three academic medical centers between 2017 and 2020.The study population included 64 patients (predominantly male, mean age 21 years), all of whom were implanted with medtronic melody bioprosthetic valves (unique device identifier numbers not provided).Among all medtronic melody patients, adverse events included: jailed/occluded right pulmonary artery by the valve, valve dislodgement requiring implantation a second melody valve and right ventricular outflow tract (rvot) conduit tear/fistula.Based on the available information medtronic product may have been 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 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: 13818586
• MDR Text Key: 290289679
• Report Number: 2025587-2022-00725
• 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: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• 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: 02/17/2022
• 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): Required Intervention; Life Threatening
• Patient Age: 21 YR
• Patient Sex: Male
• Patient Weight: 59 KG