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

Model Number PB 10

Device Problem Insufficient Information (3190)

Patient Problems Myocardial Infarction (1969); Rupture (2208); Cardiovascular Insufficiency (4445)

Event Date 07/01/2020

Event Type  Death  

Manufacturer Narrative

Citation: georgiev s., et al.Munich comparative study: prospective long-term outcome of the transcatheter melody valve versus surgical pulmonary bioprosthesis with up to 12 years of follow-up.Circ cardiovasc interv., 2020 jul; 13(7):e008963.Pmid: (b)(4).Doi: 10.1161/circinterventions.119.008963.Earliest date of publish used for event date and death date.Medtronic products referenced: melody (pma# p140017, product code: npv); hancock (pma# p790007, product code: lwr); contegra (pma# h020003, product code: mwh).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 comparing decade-plus long-term outcomes between transcatheter and surgical pulmonary bioprostheses implanted for right ventricular outflow tract (rvot) obstruction.All data were collected from a single center between january 2006 and december 2018.The study population included 451 patients (mean age 19 years, mean weight 58 kg), 241 of whom were implanted with medtronic melody bioprosthetic valves, 57 with medtronic hancock valved conduits and 11 with medtronic contegra valved conduits (no serial numbers provided).Among all medtronic melody patients, 7 deaths occurred, with two deaths noted to have been procedure-related, from myocardial infarction secondary to coronary compression and conduit rupture during valve implantation.The remaining five patients died in a span of 8 months to 7 years post-implantation, with no further information provided.Based on the available information medtronic product may have been associated with the two deaths during valve implantation.Among all surgical valve/conduit patients, overall mortality was 5.2%, with some early post-operative deaths due to left ventricular failure, sepsis and neurological complications.No further information was provided.Based on the available information, medtronic product was not directly associated with the deaths.Among all medtronic melody and all surgical valve patients, adverse events included: valve failure, endocarditis, recurrent pulmonary stenosis and pulmonary regurgitation with mean transvalvular gradient increases requiring valve replacement, either by transcatheter valve-in-valve implantation or surgical replacement and antibiotic treatment.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 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: 11106282
• MDR Text Key: 224731970
• Report Number: 2025587-2021-00001
• 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: 01/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• 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: 12/09/2020
• 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): Death; Life Threatening; Required Intervention
• Patient Age: 19 YR
• Patient Weight: 58