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

Model Number 914ESA

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/08/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported, during a transfemoral transcatheter aortic valve replacement (tavr) procedure, the case went as planned with a successful implant of a 26mm sapien 3 ultra valve in a native aortic annulus.The team elected to pre-dilate the left iliac to allow for the 14fr esheath.The iliac was small and calcified so when the sheath was advanced through the iliac, the sheath tip was damaged.A compromised tip was noted on the esheath due to calcification of iliac.Post procedure, an angio was performed and the physician felt the iliac needed to be stented.The patient was stable post procedure.

Manufacturer Narrative

According to the instructions for use (ifu), cardiovascular complications, including perforation or dissection of vessels which may require intervention, are potential adverse events associated with the transfemoral transcatheter aortic valve replacement procedure.The sheath was not returned to edwards lifesciences for evaluation.In addition, no relevant imagery was provided for review.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis; therefore, a manufacturing nonconformance was unable to be determined.A device history record (dhr) and a lot history review were unable to be performed as no work order was provided.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 for sheath distal tip damaged was unable to be confirmed.A review of the ifu and training manuals revealed no deficiencies.Furthermore, no abnormalities were observed during device unpacking or preparation.As reported, ''there was damage to the tip of the first sheath.The iliac was small and calcified so when the sheath was advanced through the iliac, the sheath was damaged''.Per training manual, ''push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification''.The presence of calcification and undersized vessel diameters can create a challenging pathway for sheath insertion, as they can create friction, directly damaging the distal tip.As such, available information suggests that patient factors (calcification, undersized vessel) and may have contributed to the complaint event.In this case, the injury to the iliac cannot be confirmed, however may be related to patient/procedural factors.Since no product non-conformances or ifu/training manual deficiencies were identified, a product risk assessment (pra) escalation and corrective/preventative actions (capa) are not required.

• Brand Name: EDWARDS ESHEATH 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
• MDR Report Key: 12569570
• MDR Text Key: 274536695
• Report Number: 2015691-2021-05501
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

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 Model Number: 914ESA
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 11/18/2021
• Supplement Dates FDA Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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