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

Model Number PB 10

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Endocarditis (1834); Staphylococcus Aureus (2058)

Event Date 09/10/2014

Event Type  Injury  

Event Description

Medtronic received information from a medical journal article that described transcatheter valve replacement patients whose devices experienced definite or probable prosthetic valve endocarditis (pve) after device implant.The article was a review of 28 articles published between december 2000 and june 2013 on patients who underwent either a tavr or a transcatheter pulmonary valve replacement (tpvr).28 patients who underwent a tvpr procedure and subsequently experienced endocarditis were implanted with a model of this transcatheter pulmonary valve (tpv) implanted via the transfemoral venous approach.A separate report has been filed for two patients who subsequently expired from endocarditis-related issues.Seventeen of the tpv devices were implanted into failed homografts, conduits or valves.There was no implant information reported for the other nine devices.It was reported that all implant procedures were considered successful.The source of infection was not specified for 17 of the patients.The article indicated that the three main sources of infection for the article¿s population were respiratory infections (tpvr, 2 cases), dental interventions (tpvr, 2 cases) or skin infections (tpvr, 2 cases).The article also indicated that a history of pve existed in two of the pulmonary cases.The identified organisms were: staphylococcus aureus (present in 10 cases), streptococcus aurelius (four cases), candida albicans (four cases), streptococcus viridans (two cases), streptococcus sanguinis (two cases), streptococcus mitis (one case), haemophilus parainfluenzae (one case), corynebacterium pseudodiphtheriticum (one case), corynebacterium (one case), bartonella henselae (one case) and aspergillus fumigatus (one case).The time from device implant to identification of the infection was not reported for these devices.All patients received antibiotic therapy; in addition, 19 of the patients were treated surgically, either through cardiac surgery and valve explantation.17 of the 18 patients whose gender was listed were male.The average age was 16 years, with a range of 4-25 years (the age was not reported for 11 patients).

Manufacturer Narrative

Without device-specific identifying information, it could not be determined if any devices were explanted and returned for analysis, or if individual patient cases had previously been reported to medtronic.Given the timeframe of the reviewed articles, some of the patient/device cases may have been included in clinical study reporting prior to (b)(4) or commercial market approval.The attached spreadsheet lists patient- and device-specific information available from article's data tables, including fda patient and device codes.Prosthetic valve endocarditis after transcatheter valve replacement-a systematic review authors: ignacio j.Amat-santos, md; henrique b.Ribeiro, md; marina urena, md; ricardo allende, md; christine houde, md; elisabeth bedard, md; jean perron, md; robert delarochellière, md; jean-michel paradis, md; eric dumont, md; daniel doyle, md; siamak mohammadi, md; melanie côte, msc; jose alberto san roman, md; josep rodes-cabau, md.Jacc: cardiovascular interventions, vol.8, no.2, 2015 issn 1936-8798 http://dx.Doi.Org/10.1016/j.Jcin.2014.09.013.

Manufacturer Narrative

A medtronic field representative subsequently reported that there had been no cases of endocarditis associated with this model device at the facility of the article¿s lead author; information regarding the devices at other facilities was not provided.Without serial numbers of any devices, device history record and sterilization lot record reviews could not be performed.Endocarditis is a known adverse event, and in some cases cited in the article the sources of infection were dental and respiratory/skin infections and due to the implant procedure.The sterilization process used by medtronic uses a bga solution which has an anti-microbial kill on microorganisms such as staphylococcus and streptococcus species.This process is validated using the worst case bacillus atrophaus (gram-positive spore-forming rods), which is known to be representative of the cleanroom bioburden.There is insufficient information to determine if any of the endocarditis events in the article were attributable to a device from this model family.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MELODY TRANSCATHER PULMONARY VALVE
• 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: 4609912
• MDR Text Key: 5762642
• Report Number: 2025587-2015-00328
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PB 10
• Device Catalogue Number: PB 10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 00016 YR