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

Model Number MDT-TRANS VALVE

Device Problem Perivalvular Leak (1457)

Patient Problems Stroke/CVA (1770); Insufficiency, Valvular (1926); Myocardial Infarction (1969); Heart Failure (2206); Blood Loss (2597)

Event Date 07/16/2020

Event Type  Injury  

Manufacturer Narrative

Citation: carmona a et al.Impact of incomplete coronary revascularization on late ischemic and bleeding events after transcatheter aortic valve replacement.J clin med.2020 jul 16;9(7):2267.Doi: 10.3390/jcm9072267.Earliest date of publish used for date of event.Medtronic products referenced: corevalve (pma# p130021, pro code npt), evolut r (pma# p130021, pro code npt).Earliest approved product used for product code and pma#.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 an evaluation of the impact of incomplete revascularization on ischemic and bleeding events following transcatheter aortic valve replacement (tavr).All data were collected from a single center between november 2012 and december 2013 and then from june 2015 to june 2017.The study population included 311 patients and was predominantly female with a median age of 85 years.Of those, 115 patients were implanted with medtronic transcatheter valves: corevalve or evolut r.No serial numbers were provided.A total of 170 deaths occurred during a follow-up of approximately three years.Cardiovascular deaths accounted for 45 of the 170 overall deaths.No further details were provided about any of the deaths.Based on the available information, medtronic product was not directly associated with the deaths.Among all patients, adverse events included: valve-in-valve implantation for an unknown reason, post-implant balloon aortic valvuloplasty (reimpaction) for significant paravalvular leak (pvl) during tavr, percutaneous coronary intervention performed at an unspecified time after tavr, myocardial infarction, stroke, rehospitalization for heart failure, mild to severe pvl after tavr, immediate major and/or life-threatening bleeding (immediate: within 30 days after tavr), late major and/or life-threatening bleeding (late: more than 30 days after tavr), and bleeding requiring red blood cell transfusion (more than two units).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: MEDTRONIC TRANSCATHETER 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: 10632296
• MDR Text Key: 209977108
• Report Number: 2025587-2020-03017
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/05/2020

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: MDT-TRANS VALVE
• Device Catalogue Number: MDT-TRANS VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/05/2020
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 85 YR