MAUDE Adverse Event Report: EDWARDS LIFESCIENCES ASCENDRA 3 DELIVERY SYSTEM, 23MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9120AS23

Device Problems Burst Container or Vessel (1074); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2013

Event Type  malfunction  

Event Description

As reported by the edwards field clinical specialist [fcs], this patient was having a 23mm sapien valve implanted inside a 23mm hancock medtronic aortic valve via transapical approach.During the deployment the oversized balloon ruptured.The delivery catheter was removed and the patient was sent to the ccu in stable condition.Per the voluntary medwatch received, there was difficulty withdrawing the delivery system through the sheath and the devices were removed as one.During investigation of this event the fcs confirmed this event.It was indicated the device was kept for a short period by the facility.Eventually the device was discarded because after they removed it ¿basically one of the doctors destroyed it on the back table playing with it.¿ the delivery catheter was removed along with the sheath from the apex.There was no injury to the patient.The patient tolerated the procedure well and was transported to ccu.One week later the fcs confirmed the patient had been discharged home.

Manufacturer Narrative

The device history record (dhr) review of the affected ascendra 3 delivery system shows the device met specifications prior to distribution of device.Balloon rupture is a known potential risk associated with transcatheter valve deployment.Edwards has documented a technical summary regarding balloon ruptures ¿risk of balloon burst in a calcified aortic annulus¿-¿conclusions: in order to investigate reports of balloon burst, this technical summary aggregated all relevant historical complaint data and summarized the associated engineering evaluations performed since the beginning of 2008.This analysis confirmed that the rate of balloon burst complaints has been well below the applicable control limit and within the occurrence ranking per internal risk analysis documentation; this exercise also revealed that the balloon burst complaint rate has exhibited a significant decline since 2008.Review of all device investigations performed for balloon burst complaints confirmed that no clinical adverse events have been attributed directly to balloon burst.This technical summary outlined the engineering rationale for the link between a heavily calcified aortic annulus and increased risk for balloon rupture, and also presented fluoroscopic imagery from balloon burst complaint cases which supports this hypothesis.Finally, a literature review revealed that even though historical balloon burst rates in a large multi-center bav registry were significantly higher than internal balloon burst rates, no correlation was observed between balloon burst and clinical adverse events or reduced functional outcomes.Given the information presented in this technical summary, the current trending rates of balloon burst complaints can be deemed as clinically acceptable.There are extensive manufacturing inspections in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional balloon burst testing performed to every manufactured lot).The thv delivery system balloons are subject to increased risk of burst due to contact with a highly calcified annulus or as in this case with a pre-existing prosthetic valve that was likely stenotic and calcified.The report indicates the sapien valve was being deployed inside a pre-existing valve thus it is possible this required increased balloon expansion [the balloon was described as being oversized], leading to the balloon rupture and subsequent difficulty retrieving the ruptured balloon material/delivery system through the sheath.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.

• Brand Name: ASCENDRA 3 DELIVERY SYSTEM, 23MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: deborah deutsch ; 1 edwards way; irvine, CA 92614 ; 9497564213
• MDR Report Key: 3594053
• MDR Text Key: 4093544
• Report Number: 2015691-2014-00181
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/26/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2014
• Device Model Number: 9120AS23
• Device Lot Number: 59469479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2013
• Initial Date FDA Received: 01/27/2014
• Date Device Manufactured: 04/10/2013
• 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 Weight: 95