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

Model Number CRS

Device Problem Malposition of Device (2616)

Patient Problems Aortic Regurgitation (1716); Dyspnea (1816); Thrombosis (2100)

Event Date 04/14/2015

Event Type  Injury  

Manufacturer Narrative

Citation: latib a et al.Treatment and clinical outcomes of transcatheter heart valve thrombosis.Circ cardiovasc interv.2015 apr;8 (4):e001779.Doi: 10.1161/circinterventions.114.001779.Originally published 14 apr 2015.Earliest date of publish 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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a literature article regarding the prevalence, timing, characteristics, and optimal treatment of transcatheter heart valve thrombosis.All data were retrospectively collected from twelve centers between january 2008 and september 2013.The study population included 26 patients and was predominantly male with a mean age of 80 years.Of those, 6 patients were implanted with medtronic corevalve transcatheter valves.No serial numbers were provided.Among all patients, 3 deaths occurred.The causes of the deaths included: pneumonia (1), acute heart failure (1), and recurrent valve thrombosis at 3 months after percutaneous valve-in-valve implantation (1).The study used non-medtronic transcatheter valves in addition to the corevalve, and the type of transcatheter valve implanted in each patient who died was not reported.Based on the available information, medtronic product was not directly associated with the deaths.All patients were diagnosed with transcatheter heart valve thrombosis via echocardiography within 2 years after valve implant.Patients presented with worsening dyspnea, increased mean aortic valve pressure gradients (40.5 mmhg), or severe aortic regurgitation.Treatment for thrombosis included: medical therapy (oral vitamin k antagonists with or without bridging heparin), percutaneous valve-in-valve implantation, and surgical aortic valve replacement (corevalve case).Additional adverse events observed: low valve implant depth, and mild to moderate aortic regurgitation.Based on the available information, medtronic product was 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: 10749800
• MDR Text Key: 213503268
• Report Number: 2025587-2020-03263
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• 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
• Date Manufacturer Received: 10/06/2020
• 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: 80 YR