MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS CERTITUDE DELIVERY SYSTEM 26MM FOR SAPIEN 3 TCV; TRANSCATHETER HEART VALVE AND DELIVERY SYSTEM

Model Number 9600SDS26A

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913)

Patient Problems Stroke/CVA (1770); Stroke/CVA (1770); Death (1802); Thrombosis (2100); Thrombosis (2100); Foreign Body In Patient (2687); Foreign Body In Patient (2687)

Event Date 04/10/2019

Event Type  Death  

Event Description

While undergoing tavr, during deployment using the mfr's deployment system, the balloon ruptured.The balloon was withdrawn to the innominate artery.Retrieval of the deployment device was attempted and upon withdrawal of the device through the sheath, the distal third of balloon with catheter fractured leaving 2/3 of the balloon and approx 20mm of catheter in the innominate artery.Subsequent head ct demonstrated acute / subacute small infarcts of the bilateral cerebellar hemispheres, right posterolateral thalamus, right posterior limb and right caudate head.Ref 9600sds26.

• Brand Name: EDWARDS CERTITUDE DELIVERY SYSTEM 26MM FOR SAPIEN 3 TCV
• Type of Device: TRANSCATHETER HEART VALVE AND DELIVERY SYSTEM
• Manufacturer (Section D): EDWARDS LIFESCIENCES; irvine CA
• MDR Report Key: 8560219
• MDR Text Key: 241261852
• Report Number: 8560219
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194357
• UDI-Public: 00690103194357
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/04/2019,04/30/2019

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2019
• Device Model Number: 9600SDS26A
• Device Catalogue Number: 9600CN26A
• Device Lot Number: 60999383
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2019
• Distributor Facility Aware Date: 04/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Weight: 34