MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SAPIEN 3 UNKNOWN; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number SAPIEN 3 UNKNOWN

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

Patient Problem Infarction, Cerebral (1771)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

The dates of the events are unknown.Therefore, the first day of the date range of the event was used as the occurrence date.Article reference: kooistra, nynke h., valent mp intan-goey, francesca ziviello, geert e.Leenders, adriaan o.Kraaijeveld, pieter a.Doevendans, nicolas m.Van mieghem, michiel voskuil, and pieter r.Stella."comparison of the sapien 3 versus the acurate neo valve system: a propensity score analysis." catheterization and cardiovascular interventions (2020).Per the instructions for use (ifu), permanent or transient neurological events including stroke are potential adverse events associated with the tavr 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 tavr.Risk factors correlating with a number of patient co-morbidities have been identified.Although in many cases the root cause of the event is unable to be determined, strokes during tavr are undoubtedly multifactorial, the dominant etiology likely being intra-procedure 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 tavr and avr patients.After tavr, there appears to be a more significant proportion of early strokes occurring < 24 h post-procedure, but tavr patients with multiple co morbidities 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

As reported by our affiliates in (b)(6), per the medical article, ¿comparison of the sapien 3 versus the acurate neo valve system: a propensity score analysis¿, a retrospective study of 230 patients with symptomatic, severe aortic stenosis that received a sapien 3 valve at two dutch centers between march 2016 and november 2018 was performed.During the study period, at the 30-day outcomes, 5 patients experienced strokes.

Manufacturer Narrative

This is one of seven manufacturer reports being submitted for this article.Please reference related manufacturer report number: 2015691-2020-15117, 2015691-2020-15120, 2015691-2020-15122, 2015691-2020-15124, 2015691-2020-15128, 2015691-2020-15129, 2015691-2020-15130.

• Brand Name: SAPIEN 3 UNKNOWN
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11041741
• MDR Text Key: 223611933
• Report Number: 2015691-2020-15122
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SAPIEN 3 UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other