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

Model Number	9600LDS26A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), during a transfemoral tpvr procedure with a 26 mm sapien 3 valve, the commander delivery system balloon ruptured at the end of inflation due to a calcified pulmonary conduit.The valve was deployed and the delivery system and 24fr dryseal were removed as a unit without complication.A 26mm atlas gold balloon was inserted to post dilate without complication.The patient was transferred to the unit in stable condition.
Additional Manufacturer Narrative
Correction to h6 based on additional information.The returned device was evaluated, and the following was observed: radial balloon burst at the central area of the inflation balloon.No missing balloon material.Distal end separated by engineers in effort to take out the sheath.Per the instructions for use (ifu), balloon rupture is a potential risk of the tavr procedure.The complaint for balloon burst was confirmed upon visual inspection of the returned device.However, no manufacturing non-conformance was identified during the evaluation.Dimensional inspection of the returned balloon revealed that the balloon wall thickness was within specification.No visual abnormalities were observed on the returned sample.An existing technical summary written by edwards lifesciences has been documented for root cause analysis on balloon bursts in a calcified landing zone.The technical summary provides a rationale as to why it is unlikely that a product defect or manufacturing non-conformance contributed to this type of event, including factors on why deployment of balloons on thv delivery systems are subject to increased risk of burst in a calcified landing zone.As per reported, 'the commander delivery system balloon ruptured at the end of inflation due to a calcified pulmonary conduit'.The presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested for rated burst pressures well above their inflation pressure, calcified nodules can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.In this case, the commander delivery system balloon ruptured at the end of inflation due to a calcified pulmonary conduit.This is fda mdr reportable.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 at this time.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Common Device Name: PULMONARY VALVE, PROSTHESIS, 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: 15734548
• Report Number: 2015691-2022-09016
• Device Sequence Number: 2859227
• Product Code: NPV
• UDI-Device Identifier: 00690103193954
• UDI-Public: (01)00690103193954(17)230922(10)64005369
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P200015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2023
• Device Model Number: 9600LDS26A
• Device Catalogue Number: 9600LDS26A
• Device Lot Number: 64005369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 01/07/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown