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

Model Number EVOLUTPRO-23

Device Problem Insufficient Information (3190)

Patient Problem Thrombus (2101)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

Citation: madukauwa-david id et al.Might coronary flow influence transcatheter heart valve neo-sinus thrombosis? circ cardiovasc interv.2019 jul;12(7):e008005.Doi: 10.1161/circinterventions.119.008005.Epub 2019 jun 25.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 literature regarding an analysis of multi-detector computed tomography data and benchtop experiments to investigate the influence of coronary flow on neo-sinus thrombosis in patients following transcatheter aortic valve replacement (tavr).All clinical patient data was retrospectively collected from the resolve registry subset of tavr patients without long-term anticoagulation therapy.The study population included 146 patients and was predominantly male with a mean age of 82 years.Of those, 94 were implanted with medtronic transcatheter bioprosthetic valves: corevalve, evolut r, or evolut pro.No serial numbers were provided.Among all patients, adverse events included: valve-in-valve implantation (5 cases).It was not reported whether these cases involved a second transcatheter valve being implanted in the initial transcatheter valve or a transcatheter valve being implanted in a degenerated existing surgical valve.Based on the available information, medtronic product may have been associated with the adverse events.Among all corevalve, evolut r, and evolut pro patients, adverse events included: hyperattenuated leaflet thickening/leaflet thrombosis (22 cases).It was noted that the left and right coronary cusp had smaller thrombus volumes than the non-coronary cusp.Based on the available information, medtronic product was associated with the adverse events.No treatment or intervention was reported as a result of the observed leaflet thrombosis.No additional adverse patient effects or product performance issues were reported.

• Brand Name: EVOLUT PRO 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: 9656116
• MDR Text Key: 182593515
• Report Number: 2025587-2020-00347
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EVOLUTPRO-23
• Device Catalogue Number: EVOLUTPRO-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2020
• 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: 82 YR