MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CERTITUDE INTRODUCER SHEATH SET; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	9600IS21A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Unspecified Vascular Problem (4441)
Date of Event	02/16/2023
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 transaxillary tavr procedure with a 23mm sapien 3 ultra valve, the first 21f certitude sheath would not advance into the axillary/subclavian artery.The physician requested a new 21fr sheath.This patient was an axillary/subclavian cutdown.The physician was unable to get the second 21f certitude sheath to enter the vessel.The vessel (although not heavily calcified), was very thin walled and deteriorated.The vascular surgeon's were called to repair the vessel.After the repair, it was determined that this patient would be rescheduled as a transaortic approach.Per the fcs, the physician did not allege the edwards devices were deficient in some way.The physicians felt the vascular injury occurred with the first certitude sheath.Upon removal it appeared the tip of the first certitude sheath was damaged.The devices were prepped correctly.At this time, the patient has not been rescheduled.A 3 mensio and photo have been provided for review.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for additional information from a product investigation.The complaints for ''introduce sheath into patient - unable to introduce sheath'' and ''general risk - distal tip damage'' were confirmed with the returned imagery.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, review of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were reported during device unpacking or preparation.A review of edwards lifesciences risk management documentation was performed for this case.Aortic valve replacement using the s3u/certitude system by transaxillary approach is not an indicated use.The risk management file captures risks for indicated device use only.Therefore, the related hazardous situation/harm that occurred in this complaint is not captured in risk management documentation.The review of the risk management file is complete, and no further action is required at this time.As reported ''the first 21f certitude sheath would not advance into the axillary/subclavian artery.[.] upon removal it appeared the tip of the first certitude sheath was damaged.'' per imaging evaluation, calcification and tortuosity were noted in the patient's access vessel.Post-procedural image also confirms the distal tip damage.Tortuosity can subject the sheath to sub-optimal angles which can also increase resistance and difficulty inserting.Similarly, calcification can reduce the vessel diameter creating a constrained effect on the sheath during insertion, further increasing difficulty.Calcified nodules can also damage the sheath distal tip during insertion leading to the reported damage.As such, available information suggests that patient factors (tortuosity, calcification) may have contributed to the reported event.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 INTRODUCER SHEATH SET
• 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: 16513116
• Report Number: 2015691-2023-11349
• Device Sequence Number: 6316525
• Product Code: NPT
• UDI-Device Identifier: 00690103194180
• UDI-Public: (01)00690103194180(17)240612(10)64419493
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 04/28/2023

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: 06/12/2024
• Device Model Number: 9600IS21A
• Device Catalogue Number: 9600IS21A
• Device Lot Number: 64419493
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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 Age: 81 YR
• Patient Sex: Female