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

Model Number HTPV254952

Device Problems Partial Blockage (1065); Fracture (1260)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 06/02/2017

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product remains implanted; therefore, no product analysis can be performed.  conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that two years and six months after the implant of this transcatheter bioprosthetic pulmonary valve, two balloon dilations of the right ventricular outflow tract (rvot) were performed due to right ventricular outflow tract (rvot) obstruction and increased right ventricle pressure.A second transcatheter bioprosthetic pulmonary valve was then implanted, valve-in-valve.One day post valve-in-valve, no significant stenosis or regurgitation were noted.No additional adverse patient effects were reported.

Manufacturer Narrative

Report source pma / 510(k) #: correction to p140017.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information was received that the cause of the right ventricular outflow tract obstruction and increased right ventricle pressures was a stent fracture.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information was received that the previous reports were submitted on a product that was not marketed/commercially distributed and not similar to a device marketed/commercially distributed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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: HARMONY TRANSCATHETER PULMONIC VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8240024
• MDR Text Key: 132804399
• Report Number: 2025587-2019-00156
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/09/2019

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: HTPV254952
• Device Catalogue Number: HTPV254952
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 12/28/2018; 01/11/2019; 03/15/2019
• Supplement Dates FDA Received: 01/11/2019; 01/31/2019; 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 30