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

Model Number THV VALVE UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Arrhythmia (1721); Regurgitation (2259); Stenosis (2263)

Event Date 11/15/2019

Event Type  Injury  

Manufacturer Narrative

The implanted valve model and size is unknown.Possible valve used ¿ edwards sapien transcatheter heart valve ¿ pma p110021, edwards sapien xt transcatheter heart valve ¿ pma p130009, or edwards sapien 3 transcatheter heart valve ¿ pma p140031.Per the instructions for use (ifu), conduction system defects (heart block) which may require a permanent pacemaker are potential adverse events associated with balloon aortic valvuloplasty, deployment of the prosthetic valve, and the overall tavr procedure.According to the valve academic research consortium (varc) guidelines, the close anatomical relationship between the aortic valve complex and the branching atrioventricular bundle may provide an explanation for these complications of the tavr procedure.According to literature review, and as documented in a clinical technical summary written by edwards lifesciences, atrioventricular conduction disturbances after tavr are associated with many patient related and procedural related factors, including pre-operative co-morbid status, the degree and bulkiness of aortic valve and annular calcification, inter-ventricular septal thickness, pre-existing electrocardiogram abnormalities, the depth of prosthesis implantation, and the profile of the implanted prosthesis.Unlike conventional avr, where there may be localized trauma due to decalcification of the annulus and/or suture placement in the proximity of the av node or the bundles, tavr may cause conduction abnormalities through mechanical impingement of the conduction system by the prosthesis.The mechanisms of the development of heart block after tavr are well documented and described in the literature.It is also documented that pre-existing heart block is common in patients undergoing tavr or surgical avr and another 4-6 % will develop postoperative heart block, potentially requiring a permanent pacemaker.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results suggest/indicate procedural factors (pressure from the implanted valve on cardiac structures) may have contributed to the conduction disorder and subsequent ppm implant.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 at this time.Reference for the article: okoh ak, shah a, kang n, almaz b, resnick j, ghaffar a, chen c, haik b, cohen m, russo mj.Outcomes after transcatheter mitral valve-in-valve replacement in patients with degenerated bioprosthesis: a single-center experience.J invasive cardiol.(2019) https://www.Ncbi.Nlm.Nih.Gov/pubmed/31724535.This is one of three manufacturer reports being submitted for this case.

Event Description

As reported through an article, "outcomes after transcatheter mitral valve-in-valve replacement in patients with degenerated bioprosthesis: a single-center experience", between (b)(6) 2013 and (b)(6) 2016, a total of 15 patients had transcatheter mitral valve in valve (tm-viv) due to degenerative biological valve prosthesis at a single us center.Operative outcomes were assessed both in-hospital and at 30 days.The primary mechanism of bioprosthetic valve failure was stenosis in 7 patients (47%) and regurgitation in 8 patients (53%).Mean duration between mitral valve replacement (mvr) and transcatheter mvr was 89 months (range, 66-72 months).Failed bioprosthetic valves were replaced with sapien xt (n = 10; 67%), sapien (n = 4; 26%), or sapien 3 valves (n = 1; 7%).Procedural success was 100%.No intraoperative deaths were recorded.At 30-day follow-up, no reports of death, disabling stroke, or rehospitalization for cardiac reasons was recorded.A conduction disorder requiring the implant of a permanent pacemaker (ppm) occurred in 1 patient.

Manufacturer Narrative

Please reference related manufacturer report no: 2015691-2019-04880 and related manufacturer report no: 2015691-2019-04884.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9512270
• MDR Text Key: 174268900
• Report Number: 2015691-2019-04881
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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,Followup
• Report Date: 12/05/2019

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: THV VALVE UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 12/23/2019; 07/23/2020
• Supplement Dates FDA Received: 12/23/2019; 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention