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

Model Number 914ESJ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/14/2022

Event Type  Injury  

Manufacturer Narrative

The sheath was discarded and not available for return.Per the instructions for use (ifu), thrombosis and embolization of air, calcification or thrombus are potential adverse events associated with transcatheter aortic valve replacement and bioprosthetic heart valves.According to the mayo clinic, some causes for thromboembolism not associated with invasive procedures include advanced age, atherosclerosis, cancer, previous mi, heart failure, dm, htn, a sedentary lifestyle, certain medications, and smoking.It is the natural tendency of the body to form a clot on foreign objects in the vascular space.These patients are anticoagulated for the procedure and interventional best practices mandate meticulous wiping and flushing of the devices to prevent and/or remove the clot.The thv training manuals and ifu instruct the operator to administer heparin and maintain the act at = 250 sec.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The exact cause of the reported event was unable to be determined, the physician mentioned it was unknown whether the cause of the thrombus might be the dissection or cut-down.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 adverse event is not required at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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 corrective or preventative actions are required.Adverse event without allegation of a device malfunction.

Event Description

As reported by our affiliates in japan, on postoperative day (pod) two (2), there found a full occlusion in the left femoral artery due to thrombosis.A stent was placed there.Pain and psychroesthesia disappeared and there was no increase in lactase value.Outcome was reported recovered at a later date.Per medical opinion, this non-serious event was associated with tavr procedure, not edwards device.The physician mentioned it was unknown whether the thrombosis was caused by the dissection.The cause might be the dissection or cut-down.During a transfemoral transcatheter aortic valve replacement (tavr) for the native aortic position, a 14 fr esheath was inserted percutaneously from left femoral artery but it did not advance.It was resolved with plain old balloon angioplasty (poba) with a 6 mm balloon.A 26 mm commander delivery system was inserted but it got stuck at the puncture area.Access was changed to a cut-down.Although the delivery system went ahead in the sheath, strong resistance was felt at the incision area.Then, a 26 mm sapien 3 valve was deployed in the targeted position uneventfully.While retracting the sheath, blood leakage was found due to a damage on the liner.No treatment was required for it.Lower extremity angiography indicated a dissection from external ilia artery to common femoral artery, a decision was made to monitor it conservatively.The minimum liminal diameter of the access vessel measured 4.8 mm and moderate calcification with no tortuosity was reported.The device was discarded at the hospital and would not be returned for evaluation.No picture is also available.

• 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: 15668439
• MDR Text Key: 302398228
• Report Number: 2015691-2022-08814
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103194838
• UDI-Public: (01)00690103194838(17)230824(10)63946932
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 08/24/2023
• Device Model Number: 914ESJ
• Device Catalogue Number: N/A
• Device Lot Number: 63946932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• 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
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 60 KG