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

Model Number PB1016

Device Problem Fracture (1260)

Patient Problems Endocarditis (1834); Fistula (1862); Obstruction/Occlusion (2422); Blood Loss (2597)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

Citation: authors - brian h.Morray; doff b.Mcelhinney; younes boudjemline; marc gewillig; dennis w.Kim; elena k.Grant; martin l.Bocks; mary h.Martin\ journal name: circ cardiovasc interv.Title: multicenter experience evaluating transcatheter pulmonary valve replacement in bovine jugular vein (contegra) right ventricle to pulmonary artery conduits year and issue: 2017; 10(6) reference #: 10.1161/circinterventions.116.004914 the earliest date of publication was used for the event date for this literature article.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 the return of the product or serial numbers, no definitive conclusion can be made regarding the clinical observations.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.

Event Description

Medtronic received information via literature regarding the study of short and intermediate-term outcomes of medtronic melody transcatheter pulmonary valve replacement (tpvr) within the medtronic contegra conduit in the right ventricle to pulmonary artery position.All data was collected retrospective from multiple centers.The study population included 136 patients predominantly male, mean age 14.5 years old, mean weight of 53 kg.The serial numbers for these patients was not provided.Among all patients adverse events included: stent fractures, endocarditis, coronary artery compression, conduit stenosis, conduit re gurgitation, conduit calcification, conduit increased gradient, femoral arteriovenous fistula, conduit tear, conduit obstruction, and rvot obstruction.Based on the available information, these events may have been attributed to a 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: 6712726
• MDR Text Key: 80008331
• Report Number: 2025587-2017-01170
• 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: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PB1016
• Device Catalogue Number: PB1016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 15 YR
• Patient Weight: 53