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

Model Number PB10

Device Problems Fracture (1260); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 02/03/2014

Event Type  Injury  

Event Description

Medtronic received information that 55 months after implant of this transcatheter bioprosthetic valve, the patient presented to a hospital due to unspecified medical symptoms.A cardiac catheterization revealed increased right ventricular outflow tract pressure, although there was no observed insufficiency or increased gradients.It was reported that a fracture was suspected with another manufacturer¿s stent that had been used for pre-stenting prior to the implant of this device; the timing of the fracture of that device was not known.There was no observation of a fracture of the medtronic device.Three days after the patient presented to the hospital, dilatation of this device was performed with a 22 millimeter (mm) balloon, which resulted in a grade ii stent fracture of the medtronic valve.Two stents from other manufacturers were inserted, and a second valve of this same type was successfully implanted valv e-in-valve, and dilated with a 22 mm balloon, to resolve the patient conditions.No further adverse patient effects were reported and the device remains implanted.

Manufacturer Narrative

Product analysis: device remains implanted and will not be returned for analysis.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Conclusion: the device history record review and investigation are in process.Once the review and investigation are complete a supplemental report will be submitted.(b)(4).

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, INC.; 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: mike gaffney ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635265629
• MDR Report Key: 3658724
• MDR Text Key: 4196639
• Report Number: 2025587-2014-00093
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H080002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2011
• Device Model Number: PB10
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: No
• 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