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

Model Number PB 10

Device Problem Obstruction of Flow (2423)

Patient Problems Stenosis (2263); Regurgitation, Valvular (2335)

Event Date 09/14/2017

Event Type  Injury  

Manufacturer Narrative

Citation: franzone a et al."evolving indications for transcatheter aortic valve interventions." curr cardiol rep.2017 sep 14;19 (11): 107.Doi: 10.1007/s11886-017-0921-3.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.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a review of the progress in the field of transcatheter aortic valve replacement (tavr) including the expansion of indications for tavr as well as future clinical applications.All data were collected from a comprehensive review of data published through 2017.The overall study population included an unidentified number of patients (demographics not provided), a subset of which were implanted with either medtronic corevalve, evolut r, or melody bioprosthetic valves (no serial numbers provided).Among all patients, mortality rates were discussed.However, no specifics about any deaths were reported.Based on the available information, medtronic product was not directly associated with the deaths.Among all corevalve and evolut r patients, adverse events included: permanent pacemaker implantation, stroke/disabling stroke, re-intervention, new-onset atrial fibrillation, myocardial infarction, mild-moderate-severe paravalvular aortic regurgitation, major bleeding, and major vascular complications.Other adverse events noted concerning only corevalve patients: second valve required, conversion to surgery, valve embolization/migration, and aortic valve hospitalization.Based on the available information, medtronic product may have been associated with the adverse events.Among all melody patients, adverse events included: re-intervention and recurrent valve dysfunction defined as significant stenosis or moderate-severe regurgitation.Based on the available information, medtronic product may have been 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: 8624947
• MDR Text Key: 145541561
• Report Number: 2025587-2019-01645
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: H080002
• 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: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/20/2019
• 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): Required Intervention