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

Model Number PB1018

Device Problem Occlusion Within Device (1423)

Patient Problems Cyanosis (1798); Dyspnea (1816)

Event Date 07/02/2014

Event Type  Injury  

Event Description

Medtronic received information that this transcatheter pulmonary valve (tpv) was implanted inside another tpv of the same model after the first tpv was observed to be stenotic with increased gradients.The patient subsequently presented to the hospital with hypoxemia, cyanosis and shortness of breath, and this device was also found to be obstructed.Both tpvs were explanted and replaced with a valved conduit twelve days after the original reoperation.No other adverse patient effects were reported.The physician reported that it could not be determined why the obstructions occurred in the two devices, but that the patient anatomy and physiology were the underlying cause.

Manufacturer Narrative

The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.

Manufacturer Narrative

A separate medwatch report has been filed for the first tpv.It was reported the explanted devices would be returned.A supplemental report will be filed if additional information is received or if the devices are returned for analysis.(b)(4).

Manufacturer Narrative

To date, the device has not been returned for analysis.Based on the information available, patient anatomy and physiology likely contributed to the reported clinical observations.A supplemental report will be filed if the device is returned or additional information is received.

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 92705 ; 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: 3942021
• MDR Text Key: 4579845
• Report Number: 2025587-2014-00487
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H080002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2014
• 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: 00010 YR