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

Model Number ENVEOR-L

Device Problem Difficult to Advance (2920)

Patient Problems Intimal Dissection (1333); Vascular Dissection (3160)

Event Date 09/18/2020

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 prior to the implant of this transcatheter bioprosthetic valve, a 14 french(fr) introducer sheath was inserted without resistance.The right external iliac artery on the access side had 4.3 x 4.7 mm diameter.The delivery catheter system (dcs) was inserted and was unable to be advanced due to calcification in the ascending aorta.Following implant, a dissection was observed in the right external iliac arter (eia).Dissection and thrombus obstruction occurred at the puncture site.The procedure was completed by performing a repair with 8 x 80 mm and 7 x 60 mm non-medtronic stents.Hemostasis was achieved with an 8 fr non-medtronic closure device.Medication was administered for peripheral vascular dilation.No additional adverse patient effects were reported.

Manufacturer Narrative

Additional information was received that the dissection was caused by the narrow access blood vessel.No additional adverse patient effects were reported.B5 - updated event description.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.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 there was calcification of the ascending aorta and the access site had a 4.3 x 4.7 millimeter (mm) diameter.Per the device instructions for use (ifu), patients must present with transarterial access vessels with diameters that are greater than or equal to 5 mm.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.Vascular access related complications, such as dissection and thrombus, are known potential adverse patient effects per the device ifu, and are typically related to patient factors (anatomy, comorbidities, etc.) and/or procedural effects (sheath used, user technique, puncture cut location, etc.).In this case, it was noted that there was severe calcification.This indicates that the probable cause of the dissection was patient anatomy, but this cannot be confirmed with the limited information available and a relationship to the dcs cannot be established.There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.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: 10661583
• MDR Text Key: 211034596
• Report Number: 2025587-2020-03083
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ENVEOR-L
• Device Catalogue Number: ENVEOR-L
• Device Lot Number: 0010199879
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 44