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

Model Number	916ESA
Medical Device Problem Codes	Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
After successful deployment of a 29mm sapien 3 valve in the aortic position, the esheath was removed using 1 perclose and an 8fr angioseal to obtain hemostasis.A post angiogram was performed to confirm proper hemostasis of the right femoral artery.The angiogram showed there was a filling defect and slow flow through the vessel distal to the point of access.Vascular surgery was called and a surgical cutdown of the vessel was performed.Upon further review the vascular surgeon determined the dissection of the right femoral artery was due to insertion of the esheath.When the sheath was removed it caused the dissection flap to occlude flow within the vessel.
Additional Manufacturer Narrative
Sections h6 updated device code(s) to remove the code (1316 - difficult to insert) as there was no difficulty inserting device, type of investigation, investigation findings, investigation conclusions and h10 were updated.Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures are known potential risks or adverse events associated with the overall thv procedure and may require intervention.According to the literature review, and as documented in a technical summary written by edwards lifesciences, vascular complications are a well-recognized complication of the transfemoral thv procedure in this elderly population with multiple co-morbidities.Edwards has reviewed many reports, including screening data records and source documentation of vascular complications, and has found that the root cause is typically related to a combination of vessel size, tortuosity, and calcifications.Although the incidence is decreasing with smaller sheath/delivery system sizes and physician experience, there will continue to be cases in which vascular complications will occur.The thv physician training manuals instruct on procedural considerations for sheath insertion with regards to proper screening critical to reducing vascular complications.The training manual instructs the operator on proper sheath insertion and withdrawal techniques, including pre-dilating the vessel with the edwards dilators, as needed.It also notes that calcification may reduce lumen diameter and limit or prevent the transfemoral passage of the devices.The ifu contraindicates patients with ilio-femoral vessel characteristics that would preclude safe placement of sheaths such as severe obstructive calcification or severe tortuosity.Pre-procedure screening and assessment of the femoral/iliac artery internal diameters will enable the clinician to determine if the sapien 3 valve can be delivered transfemorally.Assessment of location and amount of circumferential calcium will aid in determining areas of reduced vessel diameters.The operators are trained to measure minimum vessel diameter taking calcium into account.The physician training manual also lists the minimum recommended vessel size for each size device.Despite the best screening tools, a small percentage of patients will have femoral/iliac vessels that are not amenable to the trans-femoral approach or where increased resistance is encountered during insertion of devices.In many cases, the vessel minimum luminal diameter (mld) may be borderline or below the indicated size.In addition, significant calcification and/or tortuosity, not always appreciable on imaging, could be contributing factors to the event.The minimum required vessel diameter for a 16fr esheath is 6.0mm.In this case, the cause of the reported access vessel dissection cannot be determined.Per report, the patient access vessel mld measured 7.3mm with calcification.It is possible that there may have been some vessel calcification and/or tortuosity not appreciable on imaging that could have contributed to the event.There was no allegation or indication a product malfunction contributed to this adverse event.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.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to device being returned.Sections d9, g6, h2, h3, h6: type of investigation, investigation findings, investigation conclusions and h10 has been updated.The esheath was returned for evaluation.The returned device was visually inspected, and the following was observed: the sheath was fully expanded, and distal tip opened as designed.Minor scratches along distal end of shaft and no distal tip damage observed.Due to the nature of the complaint event no relevant functional or dimensional testing was able to be performed.There was no alleged device malfunction and no issue identified with the returned device.No further actions are required at this time.This information does not impact the event conclusion captured in the previous report.

• Brand Name: ESHEATH INTRODUCER SHEATH
• Common Device Name: 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: 13595917
• Report Number: 2015691-2022-04136
• Device Sequence Number: 5946926
• Product Code: NPT
• UDI-Device Identifier: 00690103193992
• UDI-Public: (01)00690103193992(17)230823(10)63960302
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2023
• Device Model Number: 916ESA
• Device Lot Number: 63960302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 05/20/2022; 06/07/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 06/07/2022; 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown