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

Model Number CRS

Device Problems Calcified (1077); Perivalvular Leak (1457); Material Perforation (2205)

Patient Problems Foreign Body Reaction (1868); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 04/11/2020

Event Type  Injury  

Manufacturer Narrative

Citation: liesman dr et al.Leaflet perforation or tear late after transcatheter aortic valve implantation.Jtcvs techniques; september 2020; volume 3: 92-94.Doi: 10.1016/j.Xjtc.2020.04.002.Available ahead of print april 11, 2020.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 two case reports involving leaflet perforation or tear following transcatheter aortic valve implantation.Case 1: a female patient with a medical history of breast cancer treated with chest irradiation therapy who underwent inclusion aortic root replacement with a 23 mm medtronic freestyle bioprosthetic valve (serial number not provided).Six years after freestyle implant (at approximately 64 years old), transcatheter aortic valve-in-valve implantation was performed with a 23 mm medtronic corevalve (serial number not provided).The reason for valve-in-valve implantation was unspecified structural valve degeneration of the freestyle.Immediately following corevalve implant, aortography showed mild paravalvular leak (pvl).A post-implant balloon aortic valvuloplasty was performed with a 20 mm noncompliant balloon.Afterward, minimal pvl was detected on transesophageal echocardiography.Serial follow-up transthoracic echocardiography exhibited stable mild aortic insufficiency, which was thought to be pvl.Approximately six years after corevalve implant (at 70 years old), the patient presented with new york heart association class iii symptoms.Repeat transthoracic echocardiography again showed mild aortic insufficiency, but transesophageal echocardiography revealed moderate-severe aortic insufficiency of unclear origin.Subsequently, the corevalve was surgically explanted and aortic root replacement was performed with a mechanical composite conduit (manufacturer undisclosed).The physician/author stated the intra-operative findings included: diffuse calcification of the aortic root, endothelialization of the corevalve into the aortic wall, and a 7- to 8-mm perforation at the middle of the leaflet, corresponding to the right coronary cusp.In addition, ¿significant¿ calcification was present where the perforated leaflet was abutting; however, no calcified material was sticking through the corevalve frame.The patient¿s post-operative course was uneventful.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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 10861978
• MDR Text Key: 217452740
• Report Number: 2025587-2020-03567
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• 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: 10/21/2020
• 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: 70 YR