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

Model Number PB1018

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Anemia (1706); Chest Pain (1776); Dyspnea (1816); Endocarditis (1834); Right Ventricular Dysfunction (2054); Obstruction/Occlusion (2422)

Event Date 12/23/2014

Event Type  Injury  

Event Description

Medtronic received information that approximately three years, four months post-implant of this transcatheter pulmonary bioprosthetic valve implanted in another manufacturer's valve, the patient presented with progressive exertional dyspnea, chest pain, right ventricular outflow tract (rvot) obstruction, right ventricle (rv) dilation, rv systolic dysfunction, and an echogenic mass within the valve.Also present were symptoms of endocarditis and anemia.The patient was treated with antibiotics, and a stent was placed within the infected right ventricle-pulmonary artery (rv-pa) conduit to ameliorate the rvot obstruction.The angiogram revealed this valve was not changed from its initial appearance post-implantation.No adverse patient effects were reported.There is no allegation that the valve caused or contributed to the endocarditis.However, in the physician's opinion the valve did cause or contribute to the rvot obstruction.

Manufacturer Narrative

Product analysis: the device remains implanted, therefore, no product analysis can be performed.Conclusion: 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.A review of the sterility lot record confirms that the biological indicators (bi) tested negative for both tissue and solution.No conclusion can be made to the reported clinical observations at this time.Medtronic will continue to monitor for future similar events.(b)(4).

Manufacturer Narrative

Correction to date of event - changed from (b)(6) 2014 to (b)(6) 2014.

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: 4591246
• MDR Text Key: 5632167
• Report Number: 2025587-2015-00306
• Device Sequence Number: 1
• Product Code: NPV
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2013
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2011
• 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: 00024 YR