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

Model Number PB1018

Device Problems Degraded (1153); Occlusion Within Device (1423)

Patient Problems Bacterial Infection (1735); Fever (1858)

Event Date 04/04/2012

Event Type  Injury  

Event Description

Medtronic received information that this transcatheter pulmonary valve (tpv) was implanted into a stenotic conduit after the conduit was pre-stented.Two years post-implant, the patient was admitted to a hospital with a fever.An echocardiogram showed no vegetation and blood cultures were sterile.Antibiotics were prescribed with no improvement.The patient was transferred to the device implant center, where an echocardiogram showed the tpv was stenotic, and hemophilus parainfluenza was identified in blood cultures.After successful treatment with antibiotics, the tpv was explanted and a non-medtronic aortic homograft was implanted inside the conduit.At explant, the tpv revealed partially-destructed thickened leaflets with a yellow smear.Cultures of the smear remained sterile.No subsequent adverse patient effects were reported.

Manufacturer Narrative

Haemophilus parainfluenzae is part of the normal human oropharynx flora and is a member of the hacek group of rare bacteria that is responsible for about 3% of endocarditis cases.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 confirmed that the biological indicators (bi) tested negative for both tissue and solution.There have been no additional complaints, or complaints for infection against any of the devices manufactured under this sterility lot.The sterilization process used by medtronic has an anti-microbial kill on the microorganisms such as staphylococcus and streptococcus species.The information received indicates that the endocarditis occurred 2 years post implant.Endocarditis that occurs more than 12 month after the procedure are called late prosthetic-valve endocarditis and are largely community-acquired versus a result of the manufacturing process of the valve.Based on the above investigation, the endocarditis is unlikely to be attributed to the melody tpv device and/or manufacturing process.A root cause of the reported clinical observations could not be determined.However, there is no indication that the reported endocarditis was related to the manufacture of the device.The device was not returned for analysis.The analysis/investigation will be updated and a supplemental report submitted if the device is returned.

Manufacturer Narrative

After explant, the tpv was forwarded to another facility for analysis.A supplemental report will be filed when the investigation is completed or if the device is returned to medtronic for analysis.(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 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: 3951079
• MDR Text Key: 4610318
• Report Number: 2025587-2014-00504
• 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,Followup
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2011
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2014
• 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
• Patient Age: 00025 YR