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

Model Number ENVEOR-N

Device Problems Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597); Vascular Dissection (3160)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

Product analysis: the delivery catheter system (dcs) was discarded, 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 following the implant of this transcatheter bioprosthetic valve, hemodynamics deteriorated.Perc utaneous cardiopulmonary support as initiated and it was confirmed that there was no damage to the annulus or ascending aorta.It was reported that there was bleeding near the right external iliac artery and balloon hemostasis was used.However, balloon hemostasis was inadequate and a stent was implanted.Hemodynamics improved and the procedure was completed.It was reported that the minimum access vessel diameter was 5.5 mm and that there was a possibility of injury in a small diameter area.Following insertion of a 16 fr non-medtronic sheath, the inline sheath was used.No additional adverse patient effects were reported.

Manufacturer Narrative

Conclusion: a device history record (dhr) review was performed on the delivery catheter system (dcs) and there were no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The dcs was discarded by the customer, and as such no analysis could be performed.No procedural images were provided for review.The reported event indicated that resistance was noted when advancing the dcs during the procedure.Difficulties advancing the dcs through the access vessel is known to be related to factors such as patient anatomy and physician technique, including guidewire and introducer sheath selection.It was reported that the minimum access vessel diameter was 5.5 mm and that there was a large amount of continuous calcification from the annulus to the left ventricular outflow tract.This indicated that the probable cause of the advancement difficulties was patient anatomy, but this cannot be confirmed with the limited information available.Per the physician, a dissection was identified at the time of the angiogram at the end of the implant procedure.Vascular access related complications, such as bleeding and dissection, are a known potential adverse patient effect per the evolut system instructions for use (ifu), and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).As reported, resistance was noted when advancing the dcs during the procedure and thus the dcs might have contributed to the event.Per the physician, the blood vessel diameter was as specified by the minimum access diameter of dcs, but it seemed that the blood vessel was narrow.Of note, a measurement of 5.5 millimeter (mm) near the external iliac artery was noted.There was calcification in the common iliac artery, and it was considered that a dissection near the calcification (minimum 8.5 mm) and near the external iliac artery occurred.This indicated that the probable cause of the dissection and bleeding was patient anatomy, but this cannot be confirmed with the limited information available.Based on the limited information availa ble, an assignable root cause of the vascular complication cannot be determined.There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.Following implant, hemodynamics deteriorated.Percutaneous cardiopulmonary support as initiated and it was confirmed that there was no damage to the annulus or ascending aorta.It was reported that there was bleeding near the right external iliac artery and balloon hemostasis was used.However, balloon hemostasis was inadequate and a stent was implanted.Hemodynamics improved and the procedure was completed.Hypotension is a known potential adverse effect per device ifu.It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally functioning device or model implant procedure, and a conclusive cause could not be determined from the limited information available.Updated data: d8, g1, h6 patient annex e, annex f, method 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

Additional information was received which indicated that the delivery catheter system (dcs) access site was the right femoral artery.Per the physician, a dissection was identified at the time of the angiogram at the end of the implant procedure.As reported, resistance was noted when advancing the dcs during the procedure and thus the dcs might have contributed to the event.Per the physician, the blood vessel diameter was as specified by the minimum access diameter of dcs, but it seemed that the blood vessel was narrow.Of note, a measurement of 5.5 millimeter (mm) near the external iliac artery was noted.There was calcification in the common iliac artery, and it was considered that a dissection near the calcification (minimum 8.5 mm) and near the external iliac artery occurred.Further report indicated that the dcs affected the transition site between the narrow part and the calcified part of the artery.Significant tortuous anatomy was not present.No additional adverse patient effects were reported.Updated data: patient code and device code.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
• MDR Report Key: 10596945
• MDR Text Key: 208968110
• Report Number: 2025587-2020-02948
• 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: 12/21/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: ENVEOR-N
• Device Catalogue Number: ENVEOR-N
• Device Lot Number: 0010090026
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 10/15/2020; 12/01/2020
• Supplement Dates FDA Received: 10/21/2020; 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR