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

Model Number EVOLUTR-23

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Occlusion (1984); Thrombus (2101); Obstruction/Occlusion (2422)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

Citation: al-kassou b et al.Safety and efficacy of protamine administration for prevention of bleeding complications in patients undergoing tavr.Jacc cardiovasc interv.2020 jun 22;13(12):1471-1480.Doi: 10.1016/j.Jcin.2020.03.041.Available online 15 june 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.(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 an evaluation of whether protamine administration for heparin reversal after transcatheter aortic valve replacement (tavr) affects bleeding complications and patient outcomes.All data were collected from a single center between february 2013 and may 2018.The study population included 873 patients and was predominantly female with a mean age of 81 years.Of those, 343 were implanted with medtronic evolut r or evolut pro transcatheter valves.No serial numbers were provided.Among all patients, 90 all-cause deaths occurred within one-year after tavr.Further details were provided for three of the deaths: one patient died due to hemorrhagic shock caused by massive intra-abdominal bleeding, and two patients died due to retroperitoneal bleeding at the access site.Multiple manufacturers transcatheter valve systems were involved in the study and the identities of the valve systems that were used to treat these patients was not reported.Based on the available information, medtronic product was not directly associated with the deaths.Among all patients, access site and access-related vascular injuries were observed and were classified into four types: type i, blush or minimal extravasation; type ii, moderate extravasation (less than 5 mm); type iii, major extravasation (greater than 5 mm) including vessel perforation or rupture; and type iv, vessel dissection or occlusion.Treatment included: manual compression with application of a pressure bandage (types i and ii), percutaneous transluminal angioplasty (types iii and iv), or covered stent graft implantation (types iii and iv).Additional adverse events that were observed: life-threatening or major bleeding, major vascular complications, blood transfusion, conversion to open heart surgery, stroke, myocardial infarction due to procedure-related thrombotic occlusion of the right coronary artery, and acute myocardial infarction due to a left coronary artery obstruction related to the implanted valve.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: EVOLUT R 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: 10260637
• MDR Text Key: 202695748
• Report Number: 2025587-2020-02206
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EVOLUTR-23
• Device Catalogue Number: EVOLUTR-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2020
• 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: 81 YR