MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number EVPROPLUS-34US

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

Patient Problems Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Vascular Dissection (3160); Heart Block (4444)

Event Date 11/06/2022

Event Type  Injury  

Manufacturer Narrative

Citation: ghandour et al.Migration despite stabilization of an embolized transcatheter heart valve: a word of caution.J card surg.2022 dec;37(12):5588-5590.Doi: 10.1111/jocs.17141.Epub 2022 nov 6.Earliest date of publication used for date of event.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 return of the product no definitive conclusion can be made regarding the clinical observations.Select patient information cannot be included in regulatory report due to regional privacy regulations.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.

Event Description

Medtronic received information via literature regarding a patient who underwent transcatheter aortic valve replacement (tavr) to treat severe aortic stenosis (as).  following successful placement of a medtronic evolut pro+ bioprosthetic valve in the aortic position, the valve migrated into the ascending aorta.  a second evolut pro+ valve was attempted, but was removed due to significant infolding. a third evolut pro+ valve was then successfully implanted in the aortic position.  an aortogram demonstrated no signs of paravalvular leak with the implanted valve, however it did show dissection of the left external iliac artery.  a temporary pacemaker was placed to address complete heart block and the patient sent to the intensive care unit (icu) in stable condition.  at one day post-tavr the patient exhibited hypotension and cardiogenic shock.  a transthoracic echocardiogram (tte) found hemopericardium.  a computed tomography (ct) angiogram confirmed an acute type a aortic dissection with intramural hematoma extending from the aortic root to the proximal aortic arch. in an emergent open heart surgery, immediate opening of the pericardium resulted in hemodynamic improvement with release of the pressurized hemopericardium. cardiopulmonary bypass (cpb) was initiated, and the heart was arrested through retrograde cold blood cardioplegia.  the two evolut pro+ valves that had been implanted prior were extracted.  due to extensive destruction of the aortic root, a 27-mm medtronic freestyle bioprosthetic aortic root was successfully implanted along with reconstruction of the ascending aorta and hemiarch. the patient tolerated the procedure well and had an uneventful post-operative recovery.  at 11 days post-operative the patient was discharged home.  no additional adverse patient effects or product performance issues were reported.

• Brand Name: EVOLUT PRO PLUS VALVE
• 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: 16415033
• MDR Text Key: 309944864
• Report Number: 2025587-2023-00639
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EVPROPLUS-34US
• Device Catalogue Number: EVPROPLUS-34US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening