MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS CERTITUDE DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	9600SDS29A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.H3 other text : device discarded.
Event or Problem Description
As reported by a field clinical specialist (fcs), during a tavr procedure with a 29mm sapien 3 valve in the aortic position, the certitude delivery system balloon ruptured during deployment.Valve deployed with no issues.The delivery system was retrieved with no issues.The balloon was fully inflated when it burst and there was no extra volume added to the balloon prior to inflation.The landing zone for the valve had severe calcium.Closure of ventriculotomy was uncomplicated.The balloon rupture was attributed to calcium in the anatomy.The patient is doing well.The device was discarded.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to engineering evaluation findings, correction to component code, added type of investigation, investigation findings, investigation conclusions and h10 has been added.The events reported are anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.An imagery evaluation was conducted and the balloon is burst radially, and no portions of the balloon appear to be missing.The complaint for balloon burst was confirmed based on the evaluation of the provided imagery.Available information suggests patient factors (calcification) likely contributed to the event as the event description stated, 'the landing zone for the valve had severe calcium'.The presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested to ensure the burst pressure is at or above the rated burst 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.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to updated device information.The lot number, udi, expiration and manufacturing dates have been updated.

• Brand Name: EDWARDS CERTITUDE DELIVERY SYSTEM
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18903309
• Report Number: 2015691-2024-01994
• Device Sequence Number: 9069001
• Product Code: NPT
• UDI-Device Identifier: 00690103194166
• UDI-Public: (01)00690103194166(17)250410(10)64925909
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• 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,Followup
• Report Date (Section B): 04/15/2024

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: 04/10/2025
• Device Model Number: 9600SDS29A
• Device Lot Number: 64925909
• Was Device Available for Evaluation?: No
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 03/19/2024; 04/12/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 03/19/2024; 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Male