MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION COREVALVE 26MM AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number MCS-P3-29-AOA-US

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bacterial Infection (1735); Congestive Heart Failure (1783); Death (1802); Dyspnea (1816); Endocarditis (1834); Fever (1858); Staphylococcus Aureus (2058)

Event Date 09/10/2014

Event Type  Death  

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); of the 32 patients who underwent a tavr procedure and subsequently experienced endocarditis, 13 were implanted with a model of this bioprosthetic heart valve.Three of the 13 patients experienced endocarditis from 0.5 ¿ 19 months after device implant and subsequently expired as a result of infective endocarditis.The source of infection remained undetermined in one of the three patients.A health care¿related origin (percutaneous coronary intervention and a pneumological source) was identified for the other two patients.The identified organisms were: staphylococcus lugdunensis (2 cases) and staphylococcus aureus (one case).All patients received antibiotic therapy; one of the three patients was treated surgically, either through cardiac surgery or valve explantation, although the specific intervention was not reported.The patients' symptoms included congestive heart failure, fever and dyspnea.The three patients were male.The average age was 80 years, with a range of 80-81 years.All three devices were implanted via transfemoral approach; none were valve-in-valve procedures.The article noted that potential cause of pve include: the adequacy of the sterile conditions in which the transcatheter valves are prepared and finally implanted; post-operative infective complications; device leaflet damage that may occur during valve preparation and loading; comorbidities such as diabetes, immunosuppression and renal failure; the presence of residual aortic regurgitation; unrelated dental or surgical procedures; and patient adherence to antibiotic prophylactic regimens.

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.The dates of death were not reported; the listed date of death was arbitrarily selected from within the reported timeframe to facilitate electronic submission of the report.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 or the reported deaths 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: COREVALVE 26MM AORTIC VALVE
• Type of Device: AORTIC 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: 4609860
• MDR Text Key: 5697308
• Report Number: 2025587-2015-00325
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P130021
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCS-P3-29-AOA-US
• Device Catalogue Number: MCS-P3-29-AOA-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2015
• Initial Date FDA Received: 03/17/2015
• Supplement Dates Manufacturer Received: Not provided; 04/23/2015
• Supplement Dates FDA Received: 05/11/2015; 09/18/2017
• 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): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00080 YR