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

Model Number MDT-TRANS VALVE

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Congestive Heart Failure (1783); Non specific EKG/ECG Changes (1817); Insufficiency, Valvular (1926); Left Ventricular Dysfunction (1947); Myocardial Infarction (1969); Blood Loss (2597)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

Citation: saito t et al.Impact of beta blockers on patients undergoing transcatheter aortic valve replacement: the ocean-tavi registry.Open heart.2020; 7(2): e001269.Doi: 10.1136/openhrt-2020-001269.Published online 2020 jul 7.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 g5 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.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a literature article regarding the effect of pre-procedural administration of beta blockers on the clinical outcomes of patients who underwent transcatheter aortic valve replacement (tavr).All data were retrospectively collected from a multi-center registry between october 2013 and may 2017.The study population included 2,563 patients and was predominantly female with a mean age of 85 years.An unidentified number of patients were implanted with medtronic corevalve or evolut r transcatheter valves.No serial numbers were provided.The reported clinical outcomes were for a propensity score matched cohort of 1,558 patients from the overall study population.Among all patients in the matched cohort, 95 patients died of cardiovascular causes and 154 died of non-cardiovascular causes during the two-year follow-up period.The study used non-medtronic transcatheter valves in addition to the corevalve and evolut r.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 in the matched cohort, adverse events included: new permanent pacemaker implantation, conversion to open-heart surgery, procedural myocardial infarction, ischemic stroke, hemorrhagic stroke, bleeding, vascular complications, new onset atrial fibrillation, reduced left ventricular ejection fraction (less than 50%), mild to severe paravalvular leak, patient-prosthesis mismatch, and in-hospital congestive heart failure.In-hospital congestive heart failure was defined as the requirement of intravenous injection of diuretics/inotropic agents or mechanical support (intra-aortic balloon pumping or extracorporeal membrane oxygenation) after tavr.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: 10455496
• MDR Text Key: 204506638
• Report Number: 2025587-2020-02680
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• 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
• Date Manufacturer Received: 08/05/2020
• 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: 85 YR