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

Model Number CRS

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Intimal Dissection (1333); Ventricular Tachycardia (2132); Rupture (2208); Cardiac Tamponade (2226); Regurgitation, Valvular (2335); Low Cardiac Output (2501); Vascular System (Circulation), Impaired (2572); Blood Loss (2597)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

Citation: raffa et al.In-hospital outcomes after emergency or prophylactic veno-arterial extracorporeal membrane oxygenation during transcatheter aortic valve implantation: a comprehensive review of the literature.Perfusion.2019 jul;34(5):354-363.Doi: 10.117 7/0267659118816555.Epub 2019 jan 11.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding in-hospital outcomes after extracorporeal membrane oxygenation (ecmo) during transcatheter aortic valve implantation (tavi).All data were collected from a meta-analysis review of 14 peer-reviewed publications, representing an overall study population of 102 patients (predominantly female, mean age 79 years) whom underwent tavi with ecmo.Multiple manufacturer¿s devices were implanted in the study population; an unspecified number of medtronic core valve (no serial numbers provided) were implanted.Among all patients, 28 deaths occurred.Multiple manufacturer's devices were implanted in the study population.None of the deaths were directly associated with medtronic product.Among all patients adverse events included: ecmo, left ventricle free wall rupture, aortic anulus rupture, hemodynamic instability, ventricular arrhythmias, coronary obstruction, low left ventricular output (ejection fraction <(><<)>35%), major bleeding, severe aortic regurgitation, prosthesis embolization, aortic dissection, respiratory failure, ¿prolonged pacing¿, cardiopulmonary resuscitation (cpr), tamponade, and conversion to open procedure for surgical aortic valve implant.Based on the available information medtronic product may have been associated with the adverse event(s).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: 10797309
• MDR Text Key: 215010543
• Report Number: 2025587-2020-03458
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 11/05/2020

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: 10/14/2020
• Initial Date FDA Received: 11/05/2020
• 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): Life Threatening; Required Intervention
• Patient Age: 79 YR