MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONTEGRA; CONDUIT,VALVED,PULMONIC

Model Number	PVC200
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Endocarditis (1834); Insufficiency, Valvular (1926); Pulmonary Valve Stenosis (2024); No Information (3190)
Date of Event	11/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: the device remains implanted.Conclusion: multiple attempts to gather additional information have been made; however, these attempts have been unsuccessful.Without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
Medtronic received information that 2 years and 3 months post implant of this pulmonary bioprosthetic valved conduit in a pediatric patient, it was replaced valve-in-valve.No failure mechanism was provided.No other adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was received indicating that 2 years and 3 months post implant of this pulmonary bioprosthetic valved conduit in a pediatric patient, it was replaced valve-in-valve.The patient presented with pulmonary stenosis and severe pulmonary regurgitation, secondary to gemella endocarditis.The endocarditis had been previously treated.No other adverse patient effects were reported.
Additional Manufacturer Narrative
Conclusion: the dhr review was performed on the device; there were no correlations / issues identified regarding manufacturing and sterilization.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.Gemella bacteria are primarily found in the mucous membranes of humans and other animals, particularly in the oral cavity and upper digestive tract.Gemella haemolysans has been found to be involved in pulmonary exacerbations of cystic fibrosis patients(1) as of the year 2000, it had been reported in 15 cases of human endocarditis, mainly in men with underlying valvular disease and/or poor dentition or dental manipulation.Most cases were treated with a combination of penicillin and gentamicin with a favorable outcome (2).The sterilization process used by medtronic has an anti-microbial kill on the 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.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 (3).Based on the above investigation, the endocarditis is unlikely to be attributed to the device and/or manufacturing process.Overall, a true root cause to the reported clinical observations is not determined.However, there is no indication that the reported the endocarditis were related to the manufacture of the device and it was reported that endocarditis was previously treated.One (1) carmody, lisa a.; zhao, jiangchao; schloss, patrick d.; petrosino, joseph f.; murray, susan; young, vincent b.; li, jun z.; lipuma, john j.(2013-06-01)."changes in cystic fibrosis airway microbiota at pulmonary exacerbation".Annals of the american thoracic society; 10 (3): 179¿187; 2 mosquera, j.D.; zabalza, m.; laniero, m.; blanco, j.R."endocarditis due to gemella haemolysans in a patient with hemochromatosis".Clinical microbiology and infection; 6 (10): 566¿568; 3 mylonakis, e., and calderwood, s.B.Infective endocarditis in adults.New england journal of medicine; 345 (18).1318-1330.Nov.1, 2001.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONTEGRA
• Common Device Name: CONDUIT,VALVED,PULMONIC
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6221978
• Report Number: 2025587-2017-00020
• Device Sequence Number: 893800
• Product Code: MWH
• UDI-Device Identifier: 00613994600325
• UDI-Public: 00613994600325
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: H020003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2016
• Device Model Number: PVC200
• Device Catalogue Number: 200H20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 02/28/2017
• Initial Report FDA Received Date: 01/04/2017
• Supplement Report FDA Received Date: 01/24/2017; 02/28/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 YR
• Patient Weight: 29