MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION COREVALVE TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number CRS

Device Problems Gradient Increase (1270); Perivalvular Leak (1457)

Patient Problems Aortic Regurgitation (1716); Non specific EKG/ECG Changes (1817); Insufficiency, Valvular (1926); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Sepsis (2067); Tissue Damage (2104); Cardiac Tamponade (2226); Blood Loss (2597); Pseudoaneurysm (2605)

Event Date 04/29/2019

Event Type  Injury  

Manufacturer Narrative

Citation: seppelt pc et al.Aortic valve replacement in patients with preexisting liver disease: transfemoral approach with favorable survival.Catheter cardiovasc interv.2020 jan;95(1):54-64.Doi: 10.1002/ccd.28319.Epub 2019 apr 29.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 return of the product no definitive conclusion can be made regarding the clinical observations.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the outcomes of patients with pre-existing liver disease who underwent surgical aortic valve replacement or transcatheter aortic valve replacement (tavr) through the transapical (ta-tavr) or transfemoral (tf-tavr) routes.All data were retrospectively collected from a single center between january 2004 and august 2016.The overall study population included 85 patients and was predominantly male with a mean age of 73 years.The tf-tavr subgroup comprised 30 patients and 5 of those were implanted with medtronic corevalve transcatheter bioprosthetic valves.No serial numbers were provided.For the overall study population, the most known causes of death were reported to be sepsis, major bleeding, and low cardiac output/ multi-organ failure/acute liver failure.Among all tf-tavr patients, 5 deaths occurred within one-year of the procedure.Multiple manufacturers transcatheter valves were involved in the tf-tavr subgroup, and based on the available information, medtronic product was not directly associated with the deaths.Among all tf-tavr patients, adverse events included: post-procedural permanent pacemaker implantation; reoperation due to severe bleeding; intra-procedural extracorporeal membrane oxygenation support; gastrointestinal complications (bleeding, subileus, or ileus); sepsis; unspecified infection; unspecified neurological events; major adverse cardiac events; post-procedural percutaneous coronary intervention; aneurysma spurium (pseudoaneurysm); severe aortic insufficiency or paravalvular leak; pericardial tamponade; and high aortic valve gradients.Based on the available information, medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: COREVALVE TRANSCATHETER AORTIC VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9794902
• MDR Text Key: 182596752
• Report Number: 2025587-2020-00688
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2020

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: CRS
• Device Catalogue Number: CRS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2020
• Initial Date FDA Received: 03/05/2020
• 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
• Patient Age: 73 YR