MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ENVEO R DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number ENVEOR-L

Device Problems Perivalvular Leak (1457); Incomplete Coaptation (2507); Detachment of Device or Device Component (2907)

Patient Problems Low Blood Pressure/ Hypotension (1914); Insufficiency, Valvular (1926); Valvular Insufficiency/ Regurgitation (4449)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: e volutr-29, serial/lot #: (b)(4), ubd: 22-may-2021.Product analysis: no product was returned.Conclusion: without the 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 during the attempted implant of this transcatheter bioprosthetic valve, at 80% deployment on the first attempt, review of the echocardiogram showed one of the valve leaflets appeared to not function.At the same time, blood pressure was weak (approximately 30 mm hg) and paravalvular leak was noted; the physician questioned the valve leaflet function and the valve was recaptured.During the second deployment attempt, blood pressure had slightly increased; however, the physician questioned the function of the valve leaflet.During the second recapture, the handle of the delivery catheter system (dcs) separated.The physician reassembled the handle and the valve was fully recaptured and withdrawn from the patient.Subsequently, a different valve was successfully implanted.It was reported no misload was noted during the inspection of the valve load.Upon reflection of the dcs malfunction, the physician indicated the ¿claw at the joint¿ of the dcs may have been weak.No adverse patient effects were reported.

Manufacturer Narrative

B5 - updated event description.Additional information indicated that the nonfunctional leaflets were not opening and closing.It was noted that no pre-implant or p ost-implant balloon aortic valvuloplasty (bav) was performed.No adverse patient effects were reported.Updated e -initial reporter, g1 - manufacture information; h6 - annex e and annex f 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.

Manufacturer Narrative

Correction: g3 - date mfr rec previously reported incorrectly on supplemental report as 2020-11-20.The date was corrected to 2020-11-19.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

Product analysis: upon receipt at medtronic's quality laboratory, the device was received with the handle components detached from the delivery catheter system (dcs).The device was received with the capsule partially opened.The trigger moved to fully advanced and retracted positions and locked in place when released.The tip-retrieval mechanism appeared intact.Delamination was observed over the nitinol reinforcing frame along the proximal end of the capsule.The inner member shaft and spindle hub appeared intact with no evidence of damage.Tab 3 of the actuator component was observed to be hinged inward.Tab 4 was observed to have detached from the male actuator component.The device was returned with the end cap/screw gear snap fit connected.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 delivery catheter system (dcs) was returned to medtronic for analysis with the handle components detached from the dcs, confirming the reported event.Tab 3 was observed to be hinged inward and tab 4 of the actuator component was observed to have detached from the male actuator component.Actuator separation is typically associated with broken or damaged snap fit tabs, either one tab or both, which hold the handle together.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

Device evaluation and conclusion reported below is for the valve-- the concomitant product.Product analysis: the valve (concomitant product) was returned to medtronic for analysis.The device was received in an explant kit, in its original container jar, fully submerged in clear solution.The valve was discolored showing evidence of blood contact.All leaflets were slightly stiff yet flexible.The valve exhibited signs of creasing resulting from crimping and recapturing.All leaflets were partially closed with a large gap between all free margins.All commissures appeared intact.The valve was subjected to steady flow testing, for both forward flow and back pressure.The valve was able to complete both tests, and a still image indicates the valve components functioning normally.The test sample demonstrated an increase in pressure drop with increasing flow rate which is expected and consistent with the pressure drop behavior of the standard forward flow nozzle, and the test sample demonstrated increasing leakage with increasing pressure, which is expected and consistent with leakage behavior observed on the back flow nozzle.Conclusion: the subject valve was returned to medtronic for analysis.Hypotension is a known potential adverse effect per the device ifu (instructions for use).It is an event that is highly dependent on the patient's pre-procedural condition and can occur despite a normally-functioning device or model implant procedure.Paravalvular leak (pvl) can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions, and a conclusive cause could not be determined.Pvl is a known potential adverse event listed in the device ifu.In this case, even after hemodynamics improved after recapture and second deployment of the valve, the implanting physician still questioned the leaflet function.Poor valve coaptation is a known potential adverse event per the device ifu.However the device history record and returned product analysis indicate normal valve operation.Based on the limited information received, a conclusive cause of the reported coaptation issue could not be determined.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.This event does not indicate device misuse or malfunction.Updated data: h.6 - method, results, and 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.

Manufacturer Narrative

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: ENVEO R DELIVERY SYSTEM
• 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 HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway, MN ; EI ; 7635055378
• MDR Report Key: 10780277
• MDR Text Key: 214551405
• Report Number: 2025587-2020-03414
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENVEOR-L
• Device Catalogue Number: ENVEOR-L
• Device Lot Number: 0010192245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2025587-05-28-2021-001-R
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 48 KG