MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS TRANSCATHETER ESHEATH; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number ESHEATH UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

The actual dates of the events are unknown.Per the authors, the first tmvr was performed in 2012; therefore, 01-jan-2012 has been selected as the occurrence date.In this case, the authors did not specify the valve model number and access approach (transeptal or transapical) related to these events.Possible devices used ¿ edwards retroflex introducer sheath set ¿ pma k093877, edwards expandable introducer sheath set ¿ pma p130009, edwards ascendra+ introducer sheath set ¿ pma p130009, or edwards esheath introducer set ¿ pma p140031.The edwards sapien and sapien xt transcatheter heart valves are indicated for patients with severe symptomatic calcified native aortic valve stenosis.The edwards sapien 3 transcatheter heart valve is indicated for patients with symptomatic heart disease due to severe native calcific aortic stenosis or failure of a surgical bioprosthetic aortic or mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy.Per the instructions for use (ifu), access site complications / perforation or dissection of vessels, ventricle, atrium, septum, myocardium or valvular structures that may require intervention are potential complications associated thv procedure.According to the sapien 3 valve ifu, additional precautions for transseptal replacement of a failed mitral valve bioprosthesis include: presence of devices or thrombus or other abnormalities in the caval vein precluding safe transvenous femoral access for transseptal approach; presence of atrial septal occluder device or calcium preventing safe transseptal access.Safety and effectiveness have not been established for patients with access vessels characteristics that would preclude safe placement of 14f or 16f edwards esheath introducer set, such as severe obstructive calcification or severe tortuosity.Per literature review, risk factors for apical laceration and bleeding include friable tissue, fatty apex, chronic steroid use, dilated lv with thinned walls, and hypertension during removal of the sheath.While patient characteristics are important, achieving good hemostatic control of the lv apex is one of the most critical steps in ensuring the success of the transapical procedure, particularly in the elderly with friable tissue.Additional literature review confirms there is a higher incidence of apical bleeding in female patients and patients over 80 years old.This information correlates with review of complaint history, revealing that the majority of apical bleeding complications appear to be related to surgical technique and/or diseased ventricles during the insertion or removal of the sheath.In this case, there is insufficient information to determine the cause of the reported vascular complications.The authors did not specify the nature of the vascular complications or to which of the devices used during the tmvr procedure these events were associated.There was no allegation or indication of a device malfunction.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.Reference for article: kamioka n, babaliaros v, morse ma, frisoli t, lerakis s, iturbe jm, binongo j, corrigan f, yousef a, gleason p, wells ja 4th, caughron h, dong a, rodriguez e, leshnower b, o'neill w, paone g, eng m, guyton r, block pc, greenbaum a.(2018).Comparison of clinical and echocardiographic outcomes after surgical redo mitral valve replacement and transcatheter mitral valve-in-valve therapy.Jacc cardiovasc interv.Retrieved from: https://www.Ncbi.Nlm.Nih.Gov/pubmed/29929633.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2018- 04752.

Event Description

As reported in an article, ¿comparison of clinical echocardiographic outcomes after surgical redo mitral valve replacement and transcatheter mitral valve-in-valve therapy¿, a retrospective study was performed to compare clinical outcomes of patients who underwent redo mitral valve replacement at 3 facilities.121 redo mitral valve replacement patients were identified.All patients had severely degenerated mitral bioprostheses.Sixty-two (62) of these patients underwent transcatheter mitral valve-in-valve replacement (tmvr) with the sapien, sapien xt, or sapien 3 valve from 2012 to august 2017.Echocardiographic parameters were reported according to the guidelines of the american society of echocardiography definition and the mitral valve academic research consortium (mvarc) consensus document.Transseptal tmvr was done in 48 patients; 14 patients had transapical tmvr.The major finding of the study was that there was no difference in mortality at 30 days and at 1 year between the smvr and tmvr patients despite the higher risk of tmvr patients.Echocardiographic findings after tmvr were similar to smvr at 30 days.There was a statistically significant difference in mitral gradient at 1 year, though this is likely not clinically important.Tmvr may be a good alternative to smvr in selected patients.Per the article, 2 vascular complications (1 major and 1 minor) occurred among the tmvr group during the study period.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS TRANSCATHETER ESHEATH
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8091274
• MDR Text Key: 128022311
• Report Number: 2015691-2018-04810
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESHEATH UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention