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

Model Number ENVPRO-14

Device Problem Failure to Advance (2524)

Patient Problem Vascular Dissection (3160)

Event Date 05/13/2022

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 attempted implant of a transcatheter bioprosthetic valve, via subclavian artery access with a minimum access vessel diameter of 4.9x6.6 millimeter (mm), a dissection of the left axillary artery occurred.Advancement of the delivery catheter system (dcs) was not successful.The dcs was withdrawn from the patient.A graft was placed to address the dissection.Per the physician, the thinner vascular lining in the brachial artery contributed to the dissection.The access site was changed to the left femoral artery with a minimum access diameter of 4.2x6.4mm and was accessed successfully with use of a 14f introducer sheath.The introducer sheath was removed; however, using the same dcs, the femoral artery could not accessed.A left iliac angioplasty was performed with a 7x40mm balloon.The dcs still could not access the left femoral artery.An 18fr introducer sheath was attempted without success.Dissections in the left iliac and left femoral artery were identified.Intervention included the successful placement of covered stents.A valve was not implanted.The patient was returned to the intensive care unit.No adverse patient effects were reported.

Manufacturer Narrative

Additional information was received that per the physician, the patient was unstable and the complications from the procedure added to the severity of the case, which lead to the patient's death.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 DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14566667
• MDR Text Key: 293099995
• Report Number: 2025587-2022-01530
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

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: 09/07/2023
• Device Model Number: ENVPRO-14
• Device Catalogue Number: ENVPRO-14
• Device Lot Number: 0010837780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 06/01/2022
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 63 KG