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

Model Number PB 10

Device Problems Fracture (1260); Occlusion Within Device (1423)

Patient Problems Pulmonary Regurgitation (2023); Rupture (2208); Vascular System (Circulation), Impaired (2572)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

Citation: o¿donnell c et al.Infective endocarditis following melody valve implantation: comparison with a surgical cohort.Cardiol young.2016 may 10:1-8.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.(b)(4).

Event Description

Medtronic received information via literature regarding endocarditis following a transcatheter valve implant in comparison with a surgical valve implant.All data were collected from a single center between october 2009 and may 2015.The transcatheter valve study population included 25 patients (predominantly male; mean age 18 years), all of which were implanted with medtronic melody transcatheter pulmonary valves (serial numbers not provided).The surgical valve study population included 178 patients (predominantly male; mean age 16 years), 110 of which were implanted with medtronic hancock (79), mosaic (17), contegra (5), and freestyle (9) bioprostheses (serial numbers not provided).Among the transcatheter valve patients adverse events included: 2 mild pulmonary regurgitation, 2 disruption of conduit integrity, 2 right ventricular outflow tract (rvot) perforation, 2 intra-procedural supraventricular tachycardia, 1 intra-procedural ventricular tachycardia, and 1 stent fracture without loss of stent integrity.Additionally, there were four cases of endocarditis exhibited by severe conduit obstruction and low cardiac output.Surgical repair was required for three of the four cases and antibiotic therapy was prescribed for all four patients.Among the surgical valve patients adverse events included: obstructive thrombosis with conduit implants which required surgical replacement (contegra), and four cases of endocarditis post-implant of a surgical valve (2 hancock conduits, 1 mosaic, 1 biopulmonic) all of which required surgical valve replacement.No additional adverse patient effects were reported.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MELODY TRANSCATHER 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: 5923415
• MDR Text Key: 53781106
• Report Number: 2025587-2016-01391
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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,Followup
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem 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: 08/03/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening; Required Intervention
• Patient Age: 18 YR