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

Model Number 916ESPA

Device Problem Failure to Advance (2524)

Patient Problem Perforation of Vessels (2135)

Event Date 06/08/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.Device not returned.

Event Description

As reported by a field clinical specialist (fcs), during the procedure of a 29 mm sapien 3 valve in the aortic position via transfemoral approach, a very difficult access and heavy calcium with tortuosity was noted before the case began.The first sheath scrapped the calcium and would not advance.The patient required cutdown with multiple passes of balloon angioplasty and shockwave to iliac to advance sheath.An angiogram showed perforation of right external iliac artery, covered stent placed before esheath would fully advance.After covered stents placed, new esheath advanced fully and smoothly.Valve and delivery system advanced and deployed successfully.After esheath removal, final angiogram showed dissection proximal to covered stents, so deployed self expanding stents.During procedure, patient became hypotensive due to blood loss, was transfused with blood during procedure.Patient transferred stable to recovery unit.It is unclear exactly what the cause of the perforation.The operator tried to advance the sheath, then did multiple balloon and shockwave passes and it was not until after that we did an angiogram to identify the perforation.It was suspected that it was after one of the post dilation of balloon to the iliac, but it is unclear if it was directly from the sheath, or from ballooning the artery.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information base on the device evaluation.The following sections of this report have been updated: corrected d2 common device name.Corrected h.6 component codes and investigation conclusions and added new information to h.6 type of investigation and investigation findings.The esheath plus 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.A device history record review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A review of the lot history revealed no other similar returned complaints for the trend categories.The instructions were reviewed instruction for use (ifu) for esheath plus ifu, device preparation manual, procedural training manual and no ifu/training deficiencies were identified.The complaint was unable to be confirmed as there was no returned imagery nor returned device.Additionally with no returned device, engineering was unable to be perform additional visual inspection or functional/dimensional testing.Therefore, a manufacturing non-conformance could not be identified.Reviews of the dhr and lot history showed no indication a manufacturing non-conformance contributed to the event.No ifu/training manual deficiencies were identified.As reported, "very difficult access and heavy calcium with tortuosity was noted before the case began".Tortuosity can create sub-optimal angles for navigating the sheath while interaction with heavy calcium can create added friction, stopping the sheath from advancing.Available information suggests patient factors (calcification, tortuosity) could have contributed to the event.However, a definite root cause could not be determined at this time.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment (pra) escalation or a corrective preventative action (capa) is not required.

• Brand Name: ESHEATH PLUS INTRODUCER SHEATH
• 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: 14895675
• MDR Text Key: 295225850
• Report Number: 2015691-2022-06608
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2024
• Device Model Number: 916ESPA
• Device Lot Number: 64190940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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