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

Model Number	9600SDS23A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is underway.
Event or Problem Description
As reported by an edwards lifesciences affiliate, regarding implant of a 23mm sapien 3 valve in the aortic position via carotid approach.The certitude delivery system balloon ruptured during deployment.The implanters believe a piece of calcium on the stj caused the the balloon to rupture.No harm to the patient was noted at this.
Additional Manufacturer Narrative
The device was returned for evaluation.The returned device was visually examined, and the following was observed: balloon burst j shaped.Slight bunching at distal shoulder of inflation balloon.Kink on guidewire proximal to distal shoulder.The inflation balloon single wall thickness was measured along the edges of the burst location.All measurements taken of the balloon single wall thickness met the specification.The reported was confirmed by visual examination 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 reported, the certitude delivery system balloon ruptured during deployment.The implanters believe a piece of calcium on the sinotubular junction caused the balloon to rupture.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.A review of the instructions revealed similar contents as documented in the technical summary.Therefore, the ifu/training manuals as identified in the technical summary are still in place.Review of available information suggests that patient factors (calcification) contributed to the balloon burst.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.

• 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: 17436701
• Report Number: 2015691-2023-14962
• Device Sequence Number: 6770429
• Product Code: NPT
• UDI-Device Identifier: 00690103194142
• UDI-Public: (01)00690103194142(17)240612(10)64591277
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/12/2023

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: 06/12/2024
• Device Model Number: 9600SDS23A
• Device Lot Number: 64591277
• 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: 07/14/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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
• Patient Sex: Female