MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH+ INTRODUCER SET; INTRODUCER, CATHETER

Model Number 914ESPA

Device Problems Material Puncture/Hole (1504); Material Integrity Problem (2978)

Patient Problem Great Vessel Perforation (2152)

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.The device is not returning.

Event Description

As reported by a field clinical specialist (fcs), during valve deployment of a 26 mm sapien 3 ultra valve in the aortic valve via transfemoral approach, a curl was noted on the esheath due to the patient's abdominal aortic aneurysm (aaa).The delivery system broke through the 14f sheath about 18 cm from the tip.The 26 mm valve was deployed in the aorta after repairing the aaa with a aaa graph.Patient was stable.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 investigation conclusions and investigation findings.Added new information to h.6 component codes and type of investigation.The device was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was not provided for review.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaints were unable to be confirmed.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 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.As reported ''during the deployment of a 26mm delivery system it was noted that there was a curl in the the sheath caused by the patients aaa.The delivery system broke through the 14f sheath about 18 cm from the tip.'' as the esheath was subjected to a suboptimal angle due to the presence of the abdominal aortic aneurysm as noted by the ''curl in the sheath'', damage and non-coaxial alignment between the delivery system and sheath may have been present.Non-coaxial advancement can increase friction between the delivery system, crimped valve, and sheath and lead to the valve to catch onto the liner.With further advancement, the crimped valve can tear through the liner, especially along the ''curl'' region of the sheath shaft.As such, available information suggests that patient (abdominal aortic aneurysm) and/or procedural (valve caught on liner) factors may have contributed to the reported event.However, a definitive root cause is unable to be determined at this time.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.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: EDWARDS ESHEATH+ INTRODUCER SET
• Type of Device: INTRODUCER, CATHETER
• 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: 16104160
• MDR Text Key: 306722844
• Report Number: 2015691-2023-09989
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)240406(11)2204072164315360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200258
• 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: 02/17/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2024
• Device Model Number: 914ESPA
• Device Catalogue Number: 914ESPA
• Device Lot Number: 64315360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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
• Patient Sex: Male