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

Model Number PB10F18

Device Problems Fracture (1260); Gradient Increase (1270)

Patient Problems High Blood Pressure/ Hypertension (1908); Pulmonary Insufficiency (2022); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)

Event Date 09/06/2017

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 approximately eight years and eleven months following the implant of this transcatheter pulmonary bioprosthetic valve, implanted valve-in-valve into a non-medtronic surgical valve, suprasystemic right ventricle (rv) pressure likely related to left pulmonary artery/right pulmonary artery stenosis was reported.Upon relief of the distal gradients, pulmonary insufficiency, pulmonary stenosis and several stent fractures were reported.Subsequently, a second valve was implanted valve in valve.No additional adverse patient effects were reported.

Manufacturer Narrative

Additional information received that the patient had a rv gradient of 44 mmhg which was relieved by stenting the conduit with a non-medtronic stent.Moderate central pulmonary regurgitation and type 1 stent fracture was noted.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information was received which indicated that seven years and ten months following the implant of this transcatheter pulmonary bioprosthetic valve, there was severe right ventricular hypertension due to a gradient of 60 mm hg across the valve and mild pulmonary hypertension.Following balloon dilation, there was a reduction in the gradient to 30 mm hg.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information was received that following the valve implant, a post-implant dilation was performed with a 22 mm non-medtronic balloon across transcatheter pulmonary bioprosthetic valve (tpbv) at 14 atmospheres.The conduit could not be made larger and the maximum size of the tpbv was about 22 millimeter (mm) in diameter.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MELODY TRANSCATHER PULMONARY
• 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: 8056484
• MDR Text Key: 126709192
• Report Number: 2025587-2018-03018
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2010
• Device Model Number: PB10F18
• Device Catalogue Number: PB10F18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 102