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

Model Number PB1018

Device Problems Fracture (1260); Occlusion Within Device (1423)

Patient Problems Fainting (1847); Pulmonary Valve Stenosis (2024)

Event Date 02/01/2013

Event Type  Injury  

Manufacturer Narrative

Additional information received reported the model/serial number.

Manufacturer Narrative

Conclusion: no device was returned, and no unique device identifier numbers were provided.Without this information a review of the device history record could not be performed, and no root cause could be identified.

Event Description

Medtronic received information that a (b)(6), male patient with severe right ventricular (rv) to pulmonary artery (pa) homograft stenosis was successfully implanted with a medtronic pulmonary bioprosthetic valve (model/serial not reported).Two years later, the patient was struck in the back by a rubber tire while playing at a pool, resulting in back and chest pain, general weakness, nausea, and a syncopal episode.Echocardiography revealed severe pulmonary valve stenosis with a narrowed lumen.Cardiac catheterization revealed severe rv-pa obstruction due to fractures of the valve stent struts leading to dynamic narrowing of the stent lumen.The valve integrity itself was not affected.In an intervention, a second medtronic pulmonary bioprosthetic valve was successfully implanted inside the old valve.Following the intervention the valve position and function were noted as excellent.No additional adverse patient effects were reported.

Manufacturer Narrative

The device was not returned to medtronic.(b)(4).Title: accidental stent fracture due to chest trauma after percutaneous melody valve implantation authors: sven hormann,walter knirsch, and oliver kretschmar citation: european heart journal e-publish 2013 feb 1 (doi:10.1093/eurheartj/eht025).

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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4793369
• MDR Text Key: 18446475
• Report Number: 2025587-2015-00594
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PB1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2010
• 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: 00014 YR