MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS EXPANDABLE INTRODUCER SHEATH SET; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610ES16

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 03/29/2016

Event Type  malfunction  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2016-01314.Investigation of this event is ongoing.

Event Description

As reported by our affiliates in (b)(6), during the placement of the 29mm sapien 3 valve by tf approach in the aortic position, a femoral artery dissection had to be repaired.Balloon valvuloplasty was uneventful.Upon advancing the commander with the crimped valve through the esheath, resistance was felt.Several attempts had been performed by two different physicians but the distal tip of the commander delivery system looked damaged by the fluoroscopy check.A final unsuccessful attempt had been done by a small withdrawal of the esheath and trying to advance the delivery system.The team decided to remove all the system at once and replace it with a new one.There was no problem during the insertion of the second esheath.However, both operators felt resistance during the advancement of the second delivery system through the esheath but they were able to push it out of the sheath.After the crossing the native aortic valve, the team started the deployment procedure without withdrawing the commander ds flex tip from the balloon.As a result, the balloon burst after 2 seconds of inflation.Due to the damaged balloon, it was deemed impossible to retrieve the delivery system through the esheath and all the devices had to be removed again requiring surgical support.The femoral artery was repaired with a venous patch by the vascular surgeon.After reviewing the imagery, no direct cause could be determined.The patient had a mechanical mitral valve and ppm.

Manufacturer Narrative

Review of the information clarifies ¿due to the damaged balloon and its shaft, it was impossible to retrieve the delivery system through the e-sheath and all the system have been removed again requiring surgical support.The femoral artery has been repaired by a venous patch by the vascular surgeon¿, reported under mdr number 2015691-2016-01332.This event has already been reported under mdr 2015691-2016-01314, and this report is no longer considered reportable.

• Brand Name: EDWARDS EXPANDABLE INTRODUCER SHEATH SET
• 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: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 5598669
• MDR Text Key: 43346262
• Report Number: 2015691-2016-01332
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2017
• Device Model Number: 9610ES16
• Device Lot Number: 60246381
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2016
• Initial Date FDA Received: 04/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2015
• 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): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 63