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

Model Number PB 10

Device Problem Material Rupture (1546)

Patient Problems Death (1802); Endocarditis (1834); Vascular System (Circulation), Impaired (2572); Blood Loss (2597)

Event Date 04/21/2019

Event Type  Death  

Manufacturer Narrative

Citation: nordmeyer j et al.Acute and midterm outcomes of the post-approval melody registry: a multicentre registry of transcatheter pulmonary valve implantation.Eur heart j.2019 jul 14;40(27):2255-2264.Doi: 10.1093/eurheartj/ehz201.Epub 2019 apr 21.Earliest date of publish used for event date and death 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.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the outcomes after transcatheter pulmonary valve implantation (tpvi) using the melody valve in patients with congenital heart disease.All data were retrospectively collected from 42 centers between december 2006 and september 2013.The study population included 845 patients and was predominantly male with a mean age of 21 years and a mean weight of 59 kg.All were implanted with medtronic melody transcatheter pulmonary valves.No serial numbers were provided.Among all patients, 13 deaths were reported.The causes of death were due to tpvi endocarditis (9), coronary artery compression (3), and bleeding after conduit rupture (1).Based on the available information, medtronic product was associated with these deaths.Among all patients, adverse events included: reoperation and valve explantation due to endocarditis, stenosis, stent fractures, or chronic pericardial effusion; balloon dilation of the melody valve or valve-in-valve reintervention due to pulmonary restenosis, stent fractures, or endocarditis; coronary artery compression that required surgical treatment; bleeding due to conduit rupture that required interventional treatment; bleeding due to pulmonary artery injury that required interventional or surgical treatment; valve dislodgement; obstruction of pulmonary artery branches that required interventional treatment; arrhythmia; dislocation of pacemaker/implantable cardioverter defibrillator leads; injury of a right ventricular papillary muscle; pulmonary embolism; pulmonary edema; balloon rupture that required interventional treatment; and vascular access complications that required interventional or surgical treatment.Based on the available information, medtronic product was 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9525824
• MDR Text Key: 172890775
• Report Number: 2025587-2019-03893
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• 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: 12/04/2019
• 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): Death
• Patient Age: 21 YR
• Patient Weight: 59