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

Model Number 9610ES14

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

Patient Problems Necrosis (1971); Embolism/Embolus (4438)

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.Reference article: husam a.Noor, md, ahmed s.Hossain, md, rajesh jayakumar, md, abdulla darwish, md, sadananda shivappa, md, haitham amin, md, nooraldaem yousif, md, ''polymer emboli complicating transcatheter aortic valve implantation'', jacc case report (2022).

Event Description

As reported from our affiliates in bahrain, per article ''polymer emboli complicating transcatheter aortic valve implantation'', a patient underwent an emergency tavi with a 23mm sapien 3 valve.On post operative day (pod) 3, the patient developed severe abdominal pain, acute kidney injury, and blue discoloration of the left foot.Computed tomography (ct) abdominal scan with oral and intravenous contrast showed complete thrombosis of the distal third of the superior mesenteric artery, with extensive pneumatosis intestinalis and gas in the mesenteric branches of the superior mesenteric vein and splenic vein.The patient underwent emergency exploratory laparotomy, in which the entire gangrenous bowel was resected.After 48 hours, the patient underwent follow-up exploratory laparotomy.Biopsies of the gut and the gangrenous left foot were consistent with typical findings of hydrophilic polymer emboli.The postoperative period was complicated with acute kidney injury and shock liver.The patient fully recovered and was discharged.The patient planned for conservative management with potential partial amputation of her left foot once her general condition improved with rehabilitation programs.

Manufacturer Narrative

The valve was not returned to edwards lifesciences for evaluation as it remains implanted in the patient.A device history and lot history review were unable to be performed as no work order number was provided.A review of imagery provided showed the following: the patient's left foot was discolored.Photomicrographs showed foreign emboli in small intestine and skin.The patient's access vessels were calcified and had undersized luminal diameters.Minimum luminal diameter (mld) for 14f esheath is 5.5mm.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance was unable to be determined during the evaluation.A review of the complaint history from july2021 to june 2022 revealed additional similar complaints for esheath (all models and sizes).No manufacturing non-conformities that would have contributed to the reported events 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.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 was confirmed through provided imagery.A review of the ifu and training manuals revealed no deficiencies.Furthermore, no abnormalities were observed during device unpacking or preparation.Per report, ''patient developed severe abdominal pain, acute kidney injury, and blue discoloration of the left foot'' and ''patient underwent follow-up exploratory laparotomy where a side-to-side colo-jejunal anastomosis was performed.Biopsies of the gut and the gangrenous left foot were consistent with typical findings of hydrophilic polymer emboli''.In addition, it was reported, ''patient complication presumably caused by hce was not associated with the esheath but could have originated from another catheter/device that was used during the procedure''.Per imagery, the patient's access vessels had presence of calcification and undersized vessel diameters.It is possible that the calcification and undersized vessel diameter may have contributed to the complaint event.If the sheath had interacted with calcification of the access vessel, the sheath shaft may have become damaged, resulting in the emboli.Calcification can create sharp nodules which can potentially cause the hydrophilic coding coating to separate from devices.This could also be exasperated by undersized vessel diameters which would increase contact between the sheath and the vessel.As such, patient (calcification, undersized vessel) may have contributed to the complaint event.However, as no sample was returned and no relevant device-related photos were provided for evaluation, it cannot be determined if the emboli originated from the esheath.Therefore, a definitive root cause is unable to be determined at this time.Since no manufacturing non-conformances or labeling/ifu/training deficiencies were identified, no product non-conformance was confirmed, and the complaint occurrence rate did not exceed the applicable trending control limit, no corrective/preventative action (capa) is required.A product risk assessment (pra) was previously initiated for further investigation and risk assessment for issue related to hydrophilic coating flaking on the esheath introducer set.

• Brand Name: EDWARDS ESHEATH INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 14877845
• MDR Text Key: 295113837
• Report Number: 2015691-2022-06454
• Device Sequence Number: 1
• Product Code: DYB
• 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: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 9610ES14
• 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: 06/07/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 08/02/2022
• Supplement Dates FDA Received: 08/02/2022
• 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: 92 YR
• Patient Sex: Female