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 Endocarditis (1834); Sepsis (2067); Vascular Dissection (3160)

Event Date 08/04/2017

Event Type  Death  

Manufacturer Narrative

Citation: chatterjee, a.Md et al.Transcatheter pulmonary valve implantation: a comprehensive systematic review and meta-analyses of observational studies.Journal of the american heart association.(2017) aug 4;6(8).Pii: e006432 doi 10.1161/jaha.117.006432.Earliest date of e-publish/publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information, it cannot be determined whether this event has been previously reported.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature review regarding outcomes of transcatheter pulmonary valve implantation.All data were collected from a meta-analysis review that included articles written before august 31, 2016.Nineteen articles were identified that included 1044 patients, which were implanted with either a melody transcatheter pulmonary valve or a non-medtronic valve.Serial numbers were not provided.Among all patients, deaths were attributed to sepsis/endocarditis, coronary compression or dissection.Based on the available information, these events may have been attributed to a medtronic product.However as multiple manufacturers were noted in the literature, a direct correlation could not be made between the observed adverse events and the 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: 7158462
• MDR Text Key: 96185105
• Report Number: 2025587-2018-00008
• 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: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• 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: 12/11/2017
• 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