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

Model Number PB1018

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rupture (2208); Pericardial Effusion (3271)

Event Date 04/18/2017

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.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 following the implant of this transcatheter pulmonary bioprosthetic valve, a balloon aortic valvuloplasty (bav) was performed that caused a rupture distal to the valve.Flow into the pericardium was then noted.A 39 mm covered stent was deployed and successfully contained the rupture.A second valve was implanted valve-in-valve to provide a competent pulmonary valve.A pericardial drain was placed and resulted in 170 ml of blood drained.No additional adverse patient effects were reported.

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: 6582815
• MDR Text Key: 75690556
• Report Number: 2025587-2017-00834
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00643169588196
• UDI-Public: 00643169588196
• 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
• Report Date: 04/28/2017

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 Expiration Date: 08/23/2018
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2017
• Initial Date FDA Received: 05/22/2017
• Supplement Dates Manufacturer Received: 04/28/2017
• Supplement Dates FDA Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/05/2016
• 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: 29 YR
• Patient Weight: 100