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

Model Number PB1018

Device Problems Bent (1059); Gradient Increase (1270)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758); Endocarditis (1834); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)

Event Date 04/07/2015

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product has not been returned for analysis, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.(b)(4).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 that two years following the implant of the second valve, that had been implanted valve-in-valve into another transcatheter bioprosthetic pulmonary valve, antibiotics were prescribed for culture-negative presumed endocarditis associated with acute severe valve obstruction then fever for several days.Two years and eleven days following the implant of the second valve, both valves were explanted and replaced with a non-medtronic mechanical valve due to severe mitral stenosis (mean gradient of 25-30 mmhg) and severe mitral regurgitation that resulted from an acute perforation of the valve leaflet.The cause of the perforation was not known.Upon explant, one of the distal struts with tissue was sectioned off to send for cultures by hospital pathology.No further adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, two valves were returned (valve in valve).Some of the inflow stent crowns were noted to be bent.The condition of the leaflets and commissures of the valves could not be determined due to being valve in valve.White glistening host tissue (pannus) was found attached on both outflow and inflow crowns of the valves, fusing the devices together.A piece of host tissue extended out of the outflow crowns and no vegetation was observed.Radiography showed calcification on the leaflets and embedded in the pannus found outside the valve.The presence of stent fractures could not be confirmed due to the overlapping stent frames.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.

Manufacturer Narrative

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
• 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: 6558537
• MDR Text Key: 74873086
• Report Number: 2025587-2017-00776
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00643169415874
• UDI-Public: 00643169415874
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2016
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2014
• 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
• Patient Age: 4 YR
• Patient Weight: 17