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

Model Number 914ESPJ

Device Problems Difficult to Insert (1316); Patient-Device Incompatibility (2682)

Patient Problem Perforation of Vessels (2135)

Event Date 02/01/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.H3 other text : discarded.

Event Description

Per report received from japan, a transfemoral transcatheter aortic valve replacement (tavr) with a 23mm sapien 3 ultra resilia (s3ur) valve was performed.The 1st esheath was tried to be inserted from the left femoral artery (lt-fa) by cutdown but could not be inserted, although percutaneous transluminal angioplasty (pta) with 7mm balloon catheter was also performed.Therefore, the 1st sheath was removed.No vascular complication occurred in the left access vessel.The 2nd esheath was tried to be inserted from the right femoral artery (rt-fa) via a puncture.Since the 2nd sheath could also not be inserted, pta with 7mm balloon catheter was performed in the iliac artery.Then, blood pressure gradually decreased.Angiography revealed that contrast medium leaked from near the access site.Since the leakage did not stop when a stent graft was placed, the access site was incised, and rupture of access vessel was found.Surgical repair was performed, and a decision was made to abort the tavr procedure.The implant doctor commented that the patient's vessel did not have flexibility at all.

Manufacturer Narrative

The device was not returned to edwards lifesciences for evaluation.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 this event is not required at this time.The complaint for "inability to introduce sheath" was unable to be confirmed as no device or imagery were provided.As the device was not returned, engineering was unable to perform any visual examination, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were reported during device unpacking or preparation.As reported "insertion inability of 14fr esheath+ (esp) and access vessel rupture occurred during procedure.Transfemoral transcatheter aortic valve replacement (tavr) with a 23 mm sapien 3 ultra resilia (s3ur) valve was performed.The patient had chronic kidney disease requiring dialysis.Regarding the access vessels, there was concentric calcification on the right access vessel, no tortuosity in both left and right access vessel, and the minimum luminal diameter (mld) was 5.3x5.9mm for left, 3.0x3.0mm for right." in this case, patient had restricted vessels due to calcium and small size.Sharp, calcified nodules within the patient access vessel can act as physical obstacles, while undersized vessel diameters can constrain the sheath increasing friction and leading to higher push force.As such, available information suggests that patient factors (calcification, vessel size) may have contributed to the reported event.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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• Brand Name: ESHEATH+
• 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: 18785577
• MDR Text Key: 336288284
• Report Number: 2015691-2024-01365
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESPJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2024
• 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
• Patient Age: 86 YR
• Patient Sex: Male