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

Model Number ENVEOR-N

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: evolutpro-29, serial/lot #: (b)(4), ubd: 21-apr-2022, udi#: (b)(4).Product analysis: the devices were discarded, therefore no product analysis can be performed.  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 the direct aorta approach rather than the transfemoral approach was used for the implant of this transcatheter bioprosthetic valve due to tortuosity on the abdominal aorta.During the implant procedure, a pigtail catheter with a marker was inserted into the non-coronary cusp (ncc) bottom from left femoral artery and the puncture site was determined.Thereafter, a 20fr non-medtronic sheath replaced the 5fr sheath and the valve was implanted.There was no issue with the implant position and single digit pressure gradient range was observed.Thereafter, the delivery catheter system (dcs) was removed without issue.However, the pigtail catheter could not be removed.As reported, it had been predicted that due to abdominal tortuosity and calcification it would be difficult to remove.The pigtail catheter was pushed and pulled several times, but it could not be removed.It was suspected by a physician that the pigtail catheter might have been sewn together with the thread on the 20fr dry seal.However, the ascending aorta was checked directly by ultrasound, which noted the thread was hanging.A dissection of the ascending aorta was identified from ¿that part¿ to the upper end of the transcatheter valve on the proximal side.An ascending aortic replacement was required to address the dissection.With the existing transcatheter in place it would have been difficult to address the dissection.As a result, the transcatheter valve was removed and the ascending aortic replacement along with an aortic valve replacement were then performed together.As reported, these were performed without issues.As reported, the cause of the dissection was considered to have occurred during a series events during the procedure.These series were defined as the excessive force applied to the ascending aorta by pushing and pulling the pigtail that was sewn together with the ascending aorta and/or the 20fr sheath that was placed to achieve the transcatheter coaxial alignment.It was unclear if there was a direct relationship with the valve itself.Intubation was required and consciousness returned.No additional adverse patient effects were reported.

Manufacturer Narrative

B5: additional information was received which further clarified that the non-medtronic pigtail catheter was sewn together with the thread which was hanging on the 20fr non-medtronic sheath.The pigtail catheter was successfully removed through the left femoral access site.The dissection of the ascending aorta from the puncture site (direct aorta access) to the upper end of the transcatheter valve on the proximal side.Per the physician, the dissection was unlikely a direct relationship to the valve or pigtail catheter but rather it was considered that it occurred in a series of procedures.Further, as reported, the dissection most likely occurred as the result of the force applied to the ascending aorta by pushing and pulling the pigtail catheter that was sewn together with the ascending aorta.In addition, it was also noted that the issue had already occurred when the 20fr sheath was adjusted to achieve the valve coaxial alignment.The patient was extubated and consciousness recovered with no findings of a cerebral infarction.No additional 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.

Manufacturer Narrative

Additional information was received which indicated that the acute aortic dissection, stanford type a, "which outbreak with aortic puncture acted as entry." remission was reported fifty-nice days following the valve procedure.No additional 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: 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: 10573914
• MDR Text Key: 208144920
• Report Number: 2025587-2020-02899
• 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: 11/02/2020

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: 0010260161
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 10/07/2020; 10/29/2020
• Supplement Dates FDA Received: 10/28/2020; 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 52