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

Model Number PB 10

Device Problems Calcified (1077); Gradient Increase (1270); Occlusion Within Device (1423)

Patient Problems Host-Tissue Reaction (1297); Calcium Deposits/Calcification (1758); Endocarditis (1834); Perforation (2001); Stenosis (2263); Regurgitation, Valvular (2335); Vascular System (Circulation), Impaired (2572)

Event Date 05/08/2016

Event Type  Injury  

Manufacturer Narrative

Citation: miranda wr et al.Prosthetic pulmonary valve and pulmonary conduit endocarditis: clinical, microbiological and echocardiographic features in adults.Eur heart j cardiovasc imaging.2016 aug;17(8):936-43.Doi: 10.1093/ehjci/jew086.Epub (b)(6) 2016.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding clinical and microbiological findings in adults with prosthetic pulmonary valve or right ventricle to pulmonary artery conduit infective endocarditis and to assess the yield of transthoracic and transesophageal echocardiography as diagnostic tools.All data were collected from a single center between 2000 and 2015.The study population included 17 patients (predominantly male; mean age 34 years), 2 of which were implanted with a 22 mm medtronic contegra conduit, 1 was implanted with a 29 mm medtronic hancock bioprothesis, 1 was implanted with a 31 mm medtronic hancock bioprosthesis, 1 was implanted with a 22 mm medtronic melody valve, and 1 was implanted with a 27 mm medtronic stentless valve (suspected to be a freestyle).Serial numbers not provided.Among all patients, 3 deaths occurred.Two were post-operative in-hospital deaths, 64 and 83 days respectively, due to bacteremia and fungal mediastinitis.One patient had an uncharacterized infection, underwent antibiotic therapy and had sudden death 24 days following diagnosis of infection.Based on the available information, none of the deaths were attributed to medtronic product.Among all patients, adverse events included: endocarditis/infection, mild/moderate/severe regurgitation, elevated systolic gradients, cusp perforation, severe stenosis, moderate and severe obstruction, calcification, thickened and partially destroyed cusps, and valve replacement.Multiple manufacturers were noted in the literature; based on the available information a direct correlation could not be made between the observed adverse events and medtronic product.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: 7610966
• MDR Text Key: 111378788
• Report Number: 2025587-2018-01521
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• 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: 05/30/2018
• 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
• Patient Age: 34 YR