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 Blood Loss (2597)

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).According to the instructions for use (ifu), cardiovascular complications, including perforation or dissection of vessels which may require intervention, and bleeding are potential adverse events associated with the transcatheter valve replacement procedure.Vascular complications are a well-recognized complication of the tavr procedure in this elderly population with multiple co-morbidities.Edwards has reviewed many reports, including screening data records and source documentation of vascular complications and has found that the root cause is typically related to a combination of vessel size, tortuosity and calcifications.Majority of access related bleeding complications are related to diseased vessels and/or procedural technique during the insertion or removal of the sheath and/or dilators.There are cases where the bleeding is significant and more complex intervention or transfusion is required to treat/prevent a permanent injury from occurring.Intra-operative and post procedural bleeding/ hemorrhage without an obvious source of bleeding is a rare but potentially life threatening complication of coronary/cardiac interventional procedures, and tends to occur more frequently in the presence of more aggressive anticoagulation regimens.Possible sources include puncture of the femoral artery above the inguinal ligament and above the inferior epigastric artery, allowing the resultant bleeding to extend into the retroperitoneal space, or inadvertent trauma or perforation of the annular structure or ventricles during the procedure.This type of bleeding may not be recognized until the post procedural period.The thv physician training manuals instruct on procedural considerations for sheath insertion with regards to proper screening critical to reducing vascular complications.The training manual instructs the operator on proper sheath insertion and withdrawal techniques, including pre-dilating the vessel with the edwards dilators, as needed.It also notes that calcification may reduce lumen diameter and limit or prevent transfemoral passage of the devices.The ifu contraindicates patients with ilio-femoral vessel characteristics that would preclude safe placement of sheaths such as severe obstructive calcification or severe tortuosity.Pre-procedure screening and assessment of the femoral/iliac artery internal diameters will enable the clinician to determine if the sapien valve can be delivered transfemorally.Assessment of location and amount of circumferential calcium will aid in determining areas of reduced vessel diameters.The operators are trained to measure minimum vessel diameter taking calcium into account.The physician training manual also lists the minimum recommended vessel size for each size device.In this case, the cause for the bleeding could not be determined with the limited information provided by the authors.There was no allegation or indication a device malfunction contributed to this adverse 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 at this time.

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, 10 patients had life-threatening bleeding.

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: 11041809
• MDR Text Key: 222648128
• Report Number: 2015691-2020-15124
• 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): Life Threatening; Other