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

Model Number EVOLUTR-29

Device Problems Fracture (1260); Device Difficult to Setup or Prepare (1487)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the refused the return of the device; 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 following the crimping and loading of this transcatheter bioprosthetic valve with this delivery catheter system (dcs) and a compression loading system (cls), a misload was identified prior to use of the valve.The misload was identified during the fluoro check.A bend of the strut inside the capsule was observed.The system was never inserted and the valve was removed from the dcs.One broken strut on the valve was then observed.The loader was experienced with more than 15 previous loads.It was reported that no unusual resistance was felt during loading and no difficulty was encountered during the loading process.The valve was replaced with another transcatheter bioprosthetic valve and a second dcs was used to implant the second valve.No adverse patient effects were reported.

Manufacturer Narrative

Continuation of d11: section d information references the main component of the system.Other relevant device(s) are: product id: envpro-14, serial/lot #: (b)(6), ubd: 2020-09-18, udi#: (b)(4).H6.Patient codes: c50912 replaced c76143.Device codes: added c63010 for the misload of the valve.Eval code-result: added 3252 for the fractured valve identified from photographic review.Eval code-conclusion: added 61 product analysis: the customer refused the return of the devices; therefore, no product analysis could be performed.The device history records (dhr) for the valve and frame records were reviewed.The device met all manufacturing specifications for final product release and no issues were identified that would have impacted this event.A dhr review was performed on the delivery catheter system (dcs) and there were no correlations/issues identified regarding manufacturing.The device met all applicable manufacturing specifications prior to release for distribution.There was no indication of a potential manufacturing issue, device misuse or a quality deficiency.  conclusion: it was reported that during loading of the valve, a misload occurred.The evolut pro instructions for use (ifu), contains instructions to use the integrated loading bath which features a mirror to ensure that all bioprosthesis outflow struts are symmetrical and captured in the capsule during loading.In addition, the ifu instructs to inspect the trans aortic valve (tav) under fluoroscopy to for a misloaded bioprosthesis.In this case, the inspection process per the ifu was performed and identified the reported misload prior to introduction to the patient.The evolut pro system instructions for use contains the following instructions to ensure the correct loading of tav.After positioning the tav paddles within the paddle attachment pockets, ¿hold the loading tool stationary with one hand, and with the other hand manually advance the capsule guide tube so that the distal section covers the paddle attachment pockets and the top portion of the outflow struts¿.It is important not to advance the capsule guide tube using the deployment knob at this point, as this prevents tactile detection of excess resistance that may indicate a paddle out of pocket or overlapping / bent crowns.If resistance is encountered, at this point the guide tube is retracted and the paddles reseated within the paddle attachment before attempting to repeat this step.The misload was identified during fluoroscopy check and a bend of the strut inside the capsule was observed.The valve was removed from the delivery catheter system (dcs) and one broken strut was noted.Photographs of the valve provided with the complaint showed a broken strut adjacent to paddle 1.The valve was not returned to medtronic for evaluation.Based on the information provided, the valve likely sustained damage during the misload.There was no information to indicate that the valve was damaged when it was taken out of the jar (prior to loading).In this event, the valve was replaced with another valve for implant and no adverse patient effects were reported.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: 8800074
• MDR Text Key: 151732967
• Report Number: 2025587-2019-02258
• 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
• Report Date: 07/23/2019

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: 05/30/2019
• Device Model Number: EVOLUTR-29
• Device Catalogue Number: EVOLUTR-29
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.