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

Model Number 916ESPA

Device Problems Device Damaged by Another Device (2915); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Vascular Dissection (3160)

Event Date 06/15/2023

Event Type  Injury  

Event Description

During a tavr procedure using a 29 s3ur valve via transfemoral approach, after the team got right common femoral artery (cfa) access, they reported having trouble inserting a 6 fr sheath.Once the 6 fr sheath was inserted and a wire placed, the team began to place two perclose sutures.After the first perclose, bleeding was noted, so the team placed a second perclose and continued on with the case.The team first dilated the right cfa using the 18 fr dilator and then advanced the 16 fr edwards sheath with normal effort.After a 29 mm s3ur valve was deployed, the team removed the 16 fr sheath but noted one perclose suture was inadvertently withdrawn during the sheath removal.Immediately, the patient began bleeding at the access site.The team went back in with the esheath plus to help occlude the vessel.The team then went to the contralateral side, into the left cfa with an omni flush catheter to perform and angiography.An "injury" was located in the right cfa.The team then placed a wire and balloon from the left side above the right cfa to occlude the vessel.The surgeon performed a cutdown to repair the right cfa and placed graft.Following the graft placement, hypotension ensured.The team performed an additional angiogram of the right vasculature and noted a dissection at the right common iliac artery (cia).Three stents were placed to resolve the dissection.Per follow-up with the fcs- the injury occurred before the insertion of the esheath.The implanter thought that it may have either occurred during access, " or the perclose could have punctured higher.It was also thought that the occlusion balloon could have made things worse." the patient was to "step down from icu.".

Manufacturer Narrative

The investigation is ongoing.H3 other text : device was discarded.

Manufacturer Narrative

Correction to h6; impact code, clinical code, device code, type of investigation, investigation findings, investigation conclusion.Correction to b1.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 ew, 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 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 the 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 (16 fr sheath is 6.0 mm).In this case, there was no allegation or indication a device malfunction contributed to this adverse event.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate that patient factors (vascular disease) and procedural factors caused or contributed to this 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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• 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: 17268418
• MDR Text Key: 318558044
• Report Number: 2015691-2023-14371
• 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: User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 916ESPA
• Device Catalogue Number: 916ESPA
• Device Lot Number: 65011428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• 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