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

Model Number 9600LDS29A

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2022

Event Type  malfunction  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Reference mfg report number 2015691-2022-04273.The investigation is still ongoing.Device not available for return.

Event Description

As reported by the field clinical specialist (fcs), during a transseptal tmvr procedure of a 29mm sapien 3 valve inside a non-edwards surgical valve, the balloon burst during inflation.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information based on investigation.The following sections of this report have been updated: h6 (component codes, type of investigation, investigation findings, investigation conclusions).The device was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the event.No imaging was provided.A lot history review was performed and revealed no other events relating to the reported event of balloon burst.The instructions for use (ifu)/training manuals were reviewed for guidance/instruction involving the delivery system usage.Per ifu and training manuals, do not exceed 20 seconds for inflation and deflation of the delivery system.Based on the review of the ifu/training manuals, no deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The event for balloon burst was unable to be confirmed.A review of the device history record and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.Additionally, a review of ifu/training materials revealed no deficiencies.The event description states, 'the balloon burst during inflation'.While the balloons are sufficiently designed and tested for rated burst pressures well above their inflation pressure, the structure of the balloon wall may burst via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.The case notes revealed +3 cc was added to the normal volume for inflation.The prescribed nominal inflation volume is provided in the ifu.Nominal inflation volume for a 29mm commander delivery system is 33ml.It is possible once the balloon was filled with volume past the target, it was subjected to pressures high enough to cause the balloon to burst and lead to the reported event.In this case, available information suggests procedural factors (over-inflation) could have contributed to the event.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 product risk assessment nor corrective or preventative actions are required.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 13673497
• MDR Text Key: 296164227
• Report Number: 2015691-2022-04275
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)230819(10)63947104
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

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: 08/19/2023
• Device Model Number: 9600LDS29A
• Device Catalogue Number: 9600LDS29A
• Device Lot Number: 63947104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 03/04/2022
• Supplement Dates Manufacturer Received: 04/06/2022
• Supplement Dates FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• 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 Sex: Male