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

Model Number 9600IS21A

Device Problem Difficult to Insert (1316)

Patient Problem Vascular Dissection (3160)

Event Date 10/12/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by a field clinical specialist (fcs), during a transcatheter aortic valve replacement (tavr) procedure with a 23 mm sapien 3 ultra valve via carotid, resistance was felt upon advancing the certitude sheath into the carotid.The surgeon continued to advance the sheath with no problem.Upon removal of the sheath, an intimal tear was noted.The patient required a carotid repair with a vascular patch.The patient is currently in stable condition.

Manufacturer Narrative

Correction to section h6 per evaluation.The sheath was not returned to edwards lifesciences for evaluation.A review of imagery provided showed tortuosity present in access vessel.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.A device history review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A lot history review was performed and revealed no additional similar complaints.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.A review of the risk management documentation was performed, and the reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The complaint was unable to be confirmed.A review of the dhr and lot 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.Per report, ''via carotid approach, upon advancing the certitude sheath into the carotid, the surgeon noted some resistance.The surgeon continued to advance the sheath with no problem.'' review of the returned imagery revealed tortuosity present in access vessel.Additionally, it was noted that there was little calcium on the access side.Calcification can create a constrained condition, while tortuosity can subject the sheath to suboptimal angles that can lead to non-coaxial alignment between the sheath and the vessel and can lead to resistance and the reported difficulty.As such, available information suggests that patient factors (calcification, tortuosity) may have contributed to the difficulty experienced during sheath insertion.However, a definitive root cause is unable to be determined at this time.Since no manufacturing non-conformances or labeling/ifu/training deficiencies were identified, no product non-conformance was confirmed, and the complaint occurrence rate did not exceed the applicable trending control limit, no corrective/preventative actions nor product risk assessment (pra) escalation are required.

• Brand Name: EDWARDS CERTITUDE INTRODUCER
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15737348
• MDR Text Key: 303144372
• Report Number: 2015691-2022-09033
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2023
• Device Model Number: 9600IS21A
• Device Catalogue Number: N/A
• Device Lot Number: 63879293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention