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

Model Number	9600SDS23A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.The device was not returned for evaluation.
Event or Problem Description
As reported by a field clinical specialist (fcs), during a carotid tavr procedure with a 23mm sapien 3 valve, during full deployment of the valve, the 23 mm certitude delivery device balloon ruptured.The patient has a heavily calcified sinotubular junction (stj) and ascending aorta.The balloon was fully inflated when it burst.The patient remained hypotensive post deployment.Cpr was initiated and epi was given and the patient fully recovered.The valve was post dilated with a 22mm atlas gold balloon.The valve was post dilated because the physician wanted to make sure the valve was fully expanded since the delivery balloon ruptured during the end of deployment.The physician had to use some force to pull the delivery out of the sheath but there was no damage to the sheath and the balloon was intact.The patient was stable at the end of the case and there was mild paravalvular leak and no central leak observed.Per the fcs, the patient had a severely calcified stj.There was no extra volume added to the balloon prior to inflation.The patient's pressure started to drop prior to deployment, once the sapien 3 valve crossed the native valve.The perceived root cause of the hypotensive was patient and procedural factors.The patient has a history of extensive calcification and severe aortic stenosis.A two step deployment was not performed so there was an average pacing run.The device will not be returned.Pictures of the burst balloon were provided.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for additional information from a product investigation.The following section of this report has been updated: b4, g3, g6, h2, and h6.The device was not returned therefore, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.The complaint for balloon burst was confirmed by visual inspection of the imagery provided.However, no manufacturing non-conformance was identified during the evaluation.An existing technical summary 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 imagery provided, there was presence of calcium in the patient's sinotubular junction.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 pressures, 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 addition, the technical summary outlines the extensive manufacturing mitigations in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional balloon burst testing that occurs with every manufactured lot).These inspections and testing further support that it is unlikely that a defect present in manufacturing contributed to the complaint.The technical summary also outlines the instructions for valve deployment.It should be noted that these mitigations are still in place.Review of available information suggests that patient factors (calcification) contributed to the balloon burst.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.Therefore, no corrective or preventative actions nor product risk assessment (pra) is required.

• Brand Name: CERTITUDE DELIVERY SYSTEM
• Common Device Name: AORTIC 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: 16436972
• Report Number: 2015691-2023-11052
• Device Sequence Number: 11551006
• Product Code: NPT
• UDI-Device Identifier: 00690103194142
• UDI-Public: (01)00690103194142(17)240306(10)64319073
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 04/04/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2024
• Device Model Number: 9600SDS23A
• Device Catalogue Number: 9600SDS23A
• Device Lot Number: 64319073
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown