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

Model Number 9610ES14

Device Problem Peeled/Delaminated (1454)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

The esheath was returned to edwards for evaluation.Visual inspection revealed the following: sheath shaft fully expanded, liner was torn approximately 11cm from strain relief, sheath edge had serrated damage marks, two liner strands visible from sheath liner, minor liner stretching, scratch along sheath shaft, sheath liner partially delaminated near distal tip and tip opened as designed.Functional testing was unable to be performed due to the condition of the returned device.Dimensional testing was performed for the liner thickness along the liner and was found to be within specification.During the manufacturing process, visual inspections and tests are performed throughout the process.During esheath assembly and sheath shaft component of the sheath is visually inspected for defects.During final assembly, the esheath is 100% visually and dimensionally inspected by both manufacturing and quality for defects.The inspections and tests described above support that it is unlikely a manufacturing non-conformance contributed to the reported complaint.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformances that would have contributed to the complaint event.A lot history record review was performed and did not reveal any related complaints.A review of edwards lifesciences risk management documentation was performed for this case.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 for sheath liner torn was confirmed, but no product non-conformances were identified in the return device.An in-depth evaluation regarding complaints for sheath shaft liner torn has been documented in and edwards technical summary.The technical summary provides details of contributing factors for sheath shaft liner tears.The following vessel characteristics and procedural factors were identified as the root causes for encountering liner tears: tortuous patient anatomy can create sub-optimal angles that can lead to nonaxial alignment in the advancement and retrieval of the delivery system.The delivery system or balloon catheter can potentially catch on the tip or liner of the sheath and create tip damage or liner tears upon removal.The complaint mentioned mild tortuosity was present in the patient's access vessels.Calcification can damage the exposed portion of the sheath liner.Damage along the liner could lead to immediate cutting/tear or could weaken the liner.A weakened liner can tear during advancement or retrieval of the delivery system.The complaint mentioned mild calcification was present in the patient's access vessels.Scratches on the sheath are also indicative calcification.The technical summary demonstrated that there were no deficiencies in the ifu/training manuals and also outlines the extensive manufacturing mitigations in place to detect a defect or nonconformance associated with sheath shaft liner tears.There are several 100% in-process inspections (visual) performed in manufacturing process and product verification testing (functional and visual) on a sampling plan basis performed prior to lot release.It should be noted that these mitigations (from manufacturing and the ifu/training manual), as identified in the technical summary, are still in place.As such, these inspections and testing support that it is unlikely that a manufacturing non-conformance contributed to the complaint.The complaint for sheath liner strand was confirmed through evaluation of the returned device.However, no manufacturing non-conformances were identified during the evaluation.Reviews of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issues with the sheath during device preparation.Per evaluation of the returned device, it was noted that scratches were seen on the sheath shaft.Scratches are indicative of the presence of calcium.Calcification can damage the exposed portion of the sheath liner.Damage along the liner could lead to immediate cutting/tear or could weaken the liner.A weakened liner can tear during advancement or retrieval of the delivery system.It was noted in the complaint details that the patient had mild tortuosity in their access vessels.Tortuosity can create sub-optimal angles that can lead to nonaxial alignment in the advancement and retrieval of the delivery system.These angles could contribute to interaction of the delivery system with the liner of the sheath.In this case, available information suggests that patient factors (tortuosity, calcification) may have contributed to the reported event.No labeling or ifu training inadequacies were identified.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.Therefore, no product risk assessment no corrective or preventative action is required at this time.

Event Description

Per engineering confirmation, the reported strands were on the liner.As reported by our (b)(6) affiliate, after successful completion of tavr procedure by transfemoral approach during removal and withdrawal of the esheath from the right femoral access, a tear/dissection of the esheath at the point between the fully expandable portion and partially expandable portion was noted.Resulting in blood 'gushing out' during the withdrawal process.The sheath was quickly withdrawn and manual compression at puncture site was performed.There was no blood transfusion needed.There was no resistance during withdrawal was noted.No injury to the patient at the access site.As per medical opinion, it is unknown of the root cause of the event.

• Brand Name: EDWARDS EXPANDABLE INTRODUCER SET
• Type of Device: 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: 13241406
• MDR Text Key: 284975502
• Report Number: 2015691-2022-03361
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2023
• Device Model Number: 9610ES14
• Device Lot Number: 63789605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• 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 Age: 91 YR
• Patient Sex: Male