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

Model Number ENVEOR-N

Device Problem Difficult to Advance (2920)

Patient Problem Intimal Dissection (1333)

Event Date 09/12/2019

Event Type  Injury  

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, via puncture from the right common femoral artery, an attempt was made to deliver the delivery catheter system (dcs).The inline sheath was replaced with a 16 fr sheath, however the blood vessel diameter was narrow and the dcs was unable to be passed due to tortuosity.An attempt was made to insert a 20fr sheath, however the dilator was unable to be advanced.The dcs was attempted to be delivered by changing the access to the left femoral artery, however the blood vessel diameter was narrow around the bifurcation part ot the external iliac artery and internal iliac artery and the dcs was unable to be advanced.The access site was changed to the right side again and an e-sheath was inserted.The dcs was attempted to advance, however was unsuccessful due to the narrow vessel diameter.At this time, the dcs was pushed with force in the e-sheath which caused damage to the right external iliac artery and the common femoral artery.The system was changed to an evolutr system.The dcs was able to reach the annulus.After the valve was implanted, it was confirmed that contrast medium leaked from the external iliac artery and the common femoral artery and a vascular injury was reported.Hemostasis was performed for the injured external iliac artery from the inside of the blood vessel with a percutaneous transluminal angioplasty (pta) balloon.A stent graft was implanted in the external iliac artery.Surgery was performed for calcification on the blood vessels near the common femoral artery with suturing.A pta stent was implanted to repair the dissection in the left common iliac artery and internal iliac artery bifurcation.No additional adverse patient effects were reported. .

Manufacturer Narrative

Conclusion: a device history review (dhr) is not required as the product event does not indicate a potential manufacturing issue.The reported event indicates that the delivery catheter system (dcs) could not be advanced from both right and left femoral arteries.Difficulties advancing the dcs through patient anatomy is known to be related to procedural factors, user technique, and/or patient anatomy (angulation, calcification, tortuousity, etc.).In this case, it was noted that the vessels were narrow and tortuous.Additionally, it was reported that the minimum access vessel diameter was 5.1 millimeter (mm) and 4.2 mm (right and left arteries).Per the evolut pro instructions for use, patients must present with transarterial access vessels with diameters that are =5.5 mm when using models enveor-n.This indicates that the probable cause of the advancement difficulties was tortuous and narrow patient anatomy.Vascular related complications are a known potential adverse patient effect per the evolut pro 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.).Based on the information available, the right blood vessel damage was caused by pushing the delivery catheter system (dcs) via the non-medtronic sheath with excessive force, and the 16fr sheath approach contributed to the dissection on left side.There is no information to suggest a device quality deficiency that may have caused or contributed to this event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information was received that, per the physician, the right blood vessel damage was caused by pushing the delivery catheter system (dcs) via the non-medtronic sheath with excessive force, and the 16fr sheath approach contributed to the dissection on left side.Tortuosity was moderate, and calcification was mild.No additional adverse patient effects were reported.  updated data: e1 initial reporter first name 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: 9083965
• MDR Text Key: 159051138
• Report Number: 2025587-2019-02859
• 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: 01/23/2020

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: 0009763377
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 10/02/2019; 01/22/2020
• Supplement Dates FDA Received: 10/02/2019; 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Weight: 42