MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600LDS26A

Device Problems Failure to Align (2522); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is underway.

Event Description

As reported by field clinical specialist, during valve/balloon alignment of a 26mm sapien 3 valve in the mitral position (viv) via transvenous approach, the balloon was ¿pulled too far through valve¿.The delivery system was to be removed for a new system.  however, during withdrawal, the valve slipped completely off of the balloon during removal.A surgical cutdown was performed to remove the 26mm sapien 3 valve.A new 26mm sapien 3 valve was successfully placed within the pre-existing surgical mitral prosthesis.

Manufacturer Narrative

Additional information revealed that this complaint is a duplicate of manufacturer report # 2015691-2018-02206.This complaint will be investigated via manufacturer report # 2015691-2018-02206.Based on these results, this complaint is no longer considered to be a reportable event and a corrected report is being submitted.

• Brand Name: EDWARDS COMMANDER DELIVERY
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7598038
• MDR Text Key: 111015729
• Report Number: 2015691-2018-02282
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 9600LDS26A
• Device Catalogue Number: N/A
• Device Lot Number: 61171845
• Other Device ID Number: N/A
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 06/25/2018
• Supplement Dates FDA Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention