MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number EVPROPLUS-34

Device Problems Contamination /Decontamination Problem (2895); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Endocarditis (1834); Rupture (2208)

Event Date 01/20/2022

Event Type  Death  

Manufacturer Narrative

Product analysis: the valve was not returned, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant procedure of this transcatheter bioprosthetic valve the valve was re-sheathed four times due to difficult positioning.As reported, no complications occurred as result.On an unspecified date, the patient was readmitted.An echocardiogram identified a rupture just above the mitral annulus.Further, endocarditis then presented and a cerebral vascular accident (cva) occurred.Ultimately, twenty-one days following the valve implant the patient died.

Manufacturer Narrative

Product analysis: the valve was not returned, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant procedure of this transcatheter bioprosthetic valve the valve was re-sheathed four times due to difficult positioning.As reported, no complications occurred as result.On an unspecified date, the patient was readmitted.An echocardiogram identified a rupture just above the mitral annulus.Further, endocarditis then presented and a cerebral vascular accident (cva) occurred.Ultimately, twenty-one days following the valve implant the patient died.

Manufacturer Narrative

Additional information was received which reported that the valve was re-sheathed four times as the depth was too low.The cause of the positioning difficulties was the large anatomy of the annulus.14 days following the valve implant, the patient was re-admitted to the hospital.According to the physician, the inflow of the valve frame resulted in the rupture above the mitral annulus.The team elected not to perform any treatment for the rupture.Seven days after rehospitalization, endocarditis was confirmed.An echocardiogram revealed vegetation.It is unknown if the patient had undergone any recent procedures that would have led to the infection.The source of the endocarditis was not known.The cva was confirmed via imaging on the same day as the endocarditis diagnosis.It is unknown if any treatment was provided for the cva.Per the physician, the valve did not cause or contribute to the cva.It was reported that the cause of death was a combination of the rupture and the cva.Updated b3.Updated b5.Updated h6.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Updated data: h3.H6.Eval code method, eval code result, eval code conclusion product analysis: the valve remained implanted in the patient, so it was not returned to medtronic for product analysis.Procedural images were submitted to medtronic for review.The device history record and sterility record were reviewed.The device was built to specification and met all inspection and acceptance criteria.This event does not indicate device misuse or malfunction.Conclusion: review of the images by medtronic's image review team indicated the valve was recaptured four times, although, the valve can only be recaptured maximum three times per the device instructions for use (ifu).The final implant depth was 6mm at the non-coronary cusp (ncc) and 14mm at the left coronary cusp (lcc).There is a potential risk for interaction with the mitral leaflets at this depth, and this can be the cause of the mitral rupture.Fourteen days following the valve implant, the patient was re-admitted to hospital due to a rupture.It was reported per the physician that the inflow portion of the valve frame resulted in a rupture above the mitral annulus.Per the device ifu, vascular complication, such as rupture is a known potential adverse effect that can occur during any invasive procedure.Mitral rupture can potentially be affected by factors such as an implant depth which impinges on mitral valve function or damage to the mitral valve itself.Seven days after re-admission, endocarditis was confirmed.Endocarditis/infection cases that occur within two months after the procedure are known as early prosthetic-valve endocarditis and are usually acquired while the patient is in the hospital (nosocomial infe ction).These cases may also be due to introduction of the microorganism during the implant procedure (1).It was reported that there is no information provided if the patient had undergone any procedure that would have led to the infection.The source of endocard itis was unknown.As the valve remains implanted, medtronic was unable to perform a complete analysis of the valve.Cerebral vascular accident (cva) is a known potential adverse effect per the device ifu, with a variety of factors that can influence its onset.It is unknown if any treatment was provided for the cva.Per the physician, the valve did not cause or contribute to the cva.However, it was reported per the physician that the cause of death was a combination of the rupture and the cva.The report of patient death twenty-one days post-implant was ascertained as being related to the procedure.A procedure- or valve-related death is an inherent risk when the patient condition is such that a percutaneous aortic valve is needed to sustain cardiac function, and it can occur despite an ideal implant procedure or device functionality.(1) mylonakis, e., and calderwood, s.B.Infective endocarditis in adults.New england journal of medicine.345 (18).1318-1330.Nov.1, 2001.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVOLUT PRO PLUS VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13518304
• MDR Text Key: 285504935
• Report Number: 2025587-2022-00434
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2022
• Device Model Number: EVPROPLUS-34
• Device Catalogue Number: EVPROPLUS-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/09/2021
• 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): Life Threatening; Hospitalization; Required Intervention; Death