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

Model Number ENVPRO-16-US

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Intimal Dissection (1333); Death (1802); Headache (1880); Low Blood Pressure/ Hypotension (1914); Pain (1994); Vascular Dissection (3160)

Event Date 08/13/2020

Event Type  Death  

Manufacturer Narrative

Product analysis: the device was 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 during the implant of this transcatheter bioprosthetic valve, a pre-implant balloon aortic valvuloplasty (bav) was performed using a 22 millimeter (mm) non-medtronic balloon.It was reported that there was a ¿fair amount of movement back and forth across the valve¿ upon full inflation as the balloon may have been undersized as related to the minimum diameter of the annulus.During the first attempt to cross the native valve, the transcatheter valve was positioned in the left anterior oblique (lao) at 1-2 mm depth on the non-coronary cusp (ncc).Deployment continued with controlled pacing at 130 beats per minute (bpm).However, the valve dislodged into the ascending aorta.The valve was recaptured.At that time, headache was reported with a 9 out of 10 on the pain scale.Hemodynamics continued to remain stable, although a bit more hypotensive than at the start of the case.The condition was considered stable.A second deployment attempt was made and the valve was implanted successfully.The pain continued at a 9 out of 10 and hypotension remained.The valve was confirmed to be performing successfully.A transthoracic echocardiogram (tte) confirmed there was no effusion and a computed tomography angiography (cta) was immediately performed.Upon completion of the cta, it was noted that dissection had occurred in the ascending and descending aorta as well as into the arteries of the head vessels.Hypotension and pain were treated using medication.No further treatment was reported.Four days following the valve implant procedure, the patient died.The cause of death was not received.It is unknown whether an autopsy was performed.

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.Difficulties advancing the delivery catheter system (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.In this case, it was noted that the patient¿s primary access was high stick and reported as sub-optimal.This indicates that the probable cause of the advancement difficulties was patient anatomy, but this cannot be confirmed with the limited information available and a relationship to the dcs cannot be established.Potential factors that can influence dislodgement include tension applied on the dcs during positioning, calcification levels and shape of the native anatomy, and the cause of the reported dislodgement could not be conclusively determined with the limited information available.Hypotension is a known potential adverse effect per device instructions for use (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.In this case, a conclusive cause could not be determined from the limited information available and the potential relationship to the dcs cannot be established.Vascular access related complications, such as dissection, is a known potential adverse patient effect per the device ifu, and is typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).However, based on the limited information available, an assignable root cause of the vascular complication cannot be determined and the relationship to the dcs could not be established.With the limited information available, a conclusive assessment of the relationship between the death and the device could not be reached.There is no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to this event.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

A patient code was added to section h6.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 PRO 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: 10511254
• MDR Text Key: 206275854
• Report Number: 2025587-2020-02777
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00643169987210
• UDI-Public: 00643169987210
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2020

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 Expiration Date: 09/09/2021
• Device Model Number: ENVPRO-16-US
• Device Catalogue Number: ENVPRO-16-US
• Device Lot Number: 0009914677
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 10/28/2020; 11/30/2020
• Supplement Dates FDA Received: 10/28/2020; 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 82 YR