MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number EVOLUTR-34

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve, the valve was opened in preparation.It was noted that the struts in the outflow tract of the valve were deformed.It was attempted to straighten the struts in the loading system.A diamond of the valve frame broke.A new valve was used for implant.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, the valve was received via fedex inside a clear bag, in its original packaging and original container jar, fully submerged in clear solution.All leaflets were flexible and intact.Leaflets 2 (l2) and 3 (l3) were in the closed position while leaflet 1 (l1) was open towards the frame wall.All commissures were intact.Multiple bends were observed on the frame cells lateral to and including ¿c".Two frame fractures were identified on cell frame c22 and c86.Damage is suggestive of possible frame misalignment during loading.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.

Manufacturer Narrative

Conclusion: 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.The subject valve was returned to medtronic for analysis.Per the analysis, all leaflets were flexible and intact.Leaflets 2 (l2) and 3 (l3) were in the closed position while leaflet 1 (l1) was open towards the frame wall.All commissures were intact.Multiple bends were observed on the frame cells lateral to and including ¿c¿.Two frame fractures were identified on cell frame c22 and c86 confirming the event details.Damage is suggestive of possible frame misalignment during loading.The analysis confirmed multiples bends and the frame broken in two (2) locations, most likely due to overload.It should be noted that if a deformed/damaged strut had been observed, then the valve should not have been used per the evolut system instructions for use (ifu).Loading of the valve is a process in which the outcome is highly dependent on the operator experience and technique.The evolut system ifu, contains instructions to perform the bioprosthesis loading procedure in the integrated loading bath filled with cold, sterile saline (0° c to 8° c).Bath temperatures not sufficiently chilled can lead to excess loading forces and potentially damaged/broke struts during the loading process.There is no information to suggest a device quality deficiency that may have caused or contributed to this event.Updated h.6 - eval method and eval conclusion codes.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 R TRANSCATHETER 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
• MDR Report Key: 9643026
• MDR Text Key: 181978501
• Report Number: 2025587-2020-00314
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2020
• Device Model Number: EVOLUTR-34
• Device Catalogue Number: EVOLUTR-34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 01/29/2020
• Supplement Dates Manufacturer Received: 04/03/2020; 05/22/2020
• Supplement Dates FDA Received: 04/17/2020; 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1