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

Model Number ENVEOR-L

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

Patient Problem Intimal Dissection (1333)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

Citation: kadoya y et al.Exfoliated endothelium identified by transesophageal echocardiography during tavr.Jacc cardiovasc interv.2020 mar 23;13(6): e49-e50.Doi: 10.1016/j.Jcin.2019.12.004.Epub 2020 feb 26.Earliest date of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without the return of the product, no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via a literature case report regarding a (b)(6) year-old female patient who presented with severe, symptomatic aortic stenosis.The patient¿s common iliac arteries were reported to be mildly calcified and the lumen diameter was 5.5 mm.Transcatheter aortic valve replacement was performed through the right femoral artery access route.Following a pre-implant balloon aortic valvuloplasty, a 14 fr non-medtronic sheath was replaced with the enveo inline sheath.Mild resistance was noted as the enveo delivery catheter system (dcs) was advanced through the right common iliac artery.As the enveo dcs was advanced into the descending thoracic aorta, transesophageal echocardiography showed a mobile membranous structure on the dcs tip.The enveo dcs was withdrawn from the patient, but the membranous structure became entangled with the guidewire in the descending aorta.The 14 fr non-medtronic sheath was reinserted, and the guidewire was able to be removed along with the membranous structure.Subsequently, an additional 18 fr outer sheath was inserted and the enveo dcs was advanced through the outer sheath followed by successful valve implantation of a 26 mm medtronic evolut r (serial number not provided).Immediately after valve implant, access route angiography revealed a dissection of the right common iliac artery and intravascular ultrasound exhibited intimal exfoliation.Stenting was performed to repair the vessel.Pathological examination confirmed that the membranous structure was endoarterial fibrous tissue.The physician/ author concluded that the insertion of the enveo dcs had caused the dissection and the peeled off endoarterial tissue had become attached to the dcs and guidewire during the procedure.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Additional information received from the physician/author stated that medtronic product was related to the observed adverse events.The additional information received from the physician/author also provided the patient's weight.Updated data: a.4 - entered the patient's weight.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: 9946550
• MDR Text Key: 196560611
• Report Number: 2025587-2020-01209
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

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-L
• Device Catalogue Number: ENVEOR-L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 04/19/2020
• Supplement Dates FDA Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 94 YR
• Patient Weight: 39