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

Model Number SAPIEN VALVE UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 12/24/2020

Event Type  Injury  

Manufacturer Narrative

It was unknown which valve the patient received, a sapien, sapien xt or sapien 3 valve.The pma numbers are (b)(4), respectively.The date of the event(s) is unknown.Therefore, the date the article was received, (b)(6) 2020, was used as the occurrence date.Article reference: eng, marvin h., faraj kargoli, dee dee wang, tiberio m.Frisoli, james c.Lee, pedro s.Villablanca, hassan nemeh et al.Short and mid term outcomes in percutaneous mitral valve replacement using balloon expandable valves.Catheterization and cardiovascular interventions (2021).Per the instructions for use (ifu), permanent or transient neurological events including stroke are potential adverse events associated with the transcatheter valve replacement procedure and the use of the edwards thv devices.According to literature review, and as documented in a clinical technical summary written by edwards lifesciences, stroke is recognized in the literature as a well known complication in a small number of patients undergoing transcatheter valve replacement.Risk factors correlating with a number of patient comorbidities have been identified.Although in many cases the root cause of the event is unable to be determined, strokes during transcatheter valve replacement are undoubtedly multifactorial, the dominant etiology likely being intraprocedure embolic events.A transcranial doppler study during tavr demonstrated that the majority of procedural embolic events occurred during balloon valvuloplasty, manipulation of catheters across the aortic valve, and valve implantation.An analysis in patients undergoing valve surgery revealed four baseline characteristics and two procedural events that were associated with early post procedure stroke: female sex, ef < 30%, diabetes, age older than 70 years, bypass procedure time> 120 min, and calcification of the ascending aorta.Predictors of late stroke have included female sex, age older than 75 years, atrial fibrillation, and a history of or current smoking.There were no important differences in the frequency of late strokes between transcatheter valve replacement and surgical valve replacement patients.After transcatheter valve replacement, there appears to be a more significant proportion of early strokes occurring < 24 h post procedure, but transcatheter valve replacement patients with multiple comorbidities are probably at higher risk of both early and late strokes.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The cause for the stroke could not be determined with the limited information provided by the authors.However, patient factors not provided and/or the mechanisms described above are likely contributing factors for the event.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.

Event Description

Per the article, short and midterm outcomes in percutaneous mitral valve replacement using balloon expandable valves, from (b)(6) 2013 to (b)(6) 2019, a total of 88 cases of transcatheter mitral valve replacement (tmvr) were performed at single center.A total of 38, 31, and 19 patients were treated with a valve in valve, valve in ring, or valve in native mitral annulus, respectively.During the study period, 1 patient had a stroke.No additional information was available.

• Brand Name: SAPIEN VALVE UNKNOWN
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 12418602
• MDR Text Key: 270069595
• Report Number: 2015691-2021-04988
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SAPIEN VALVE UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other