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

Model Number 914ESPA

Device Problem Device Damaged by Another Device (2915)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 06/20/2023

Event Type  Injury  

Event Description

As reported by the clinical specialist, during a tf tavr case while removing the esheath the team was on unable to get control of bleeding/hemostasis.A third pre-close device was attempted unsuccessfully.The team determined that the pre-close devices failed and made a decision to perform a successful surgical repair of the artery and deployed two self-expanding stents.The heart team was not sure if the failed pre-close was a result of the esheath entering the vessel or the result of the third attempted pre-close device causing the vascular injury.The patient remained stable.

Manufacturer Narrative

Investigation is ongoing.H3 other text : device not retained.

Manufacturer Narrative

Added updated b.4 and g.3 dates for supplemental report.Corrected h.6 type of investigation, investigation findings, and investigation conclusions.The device was not returned for evaluation.A device history review (dhr) was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed and revealed no other similar complaints.Pre-procedural imagery was reviewed.Tortuosity was present in the access vessel and near the access site.The access vessel diameters are sufficient in size (>=5.5mm) for a 14f esheath plus.The ifu, device preparation manual, and procedural training manual were reviewed.No deficiencies 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 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 the failure mode is not required at this time.Since no device problem was identified affecting a distributed product, no product risk assessment (pra).Since no edwards defect, which could have resulted in the complaint, was confirmed no preventative or corrective actions are required.The interaction between the sheath and closure device was unable to be confirmed as no device/relevant imagery was provided.As the device was not returned, engineering was unable to perform any visual examination, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, a review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of the ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were reported during device unpacking or preparation.As reported, ''during a tf tavr case while removing the esheath the team was on unable to get control of bleeding/hemostasis.A third pre-close device was attempted unsuccessfully.The heart team was not sure if the failed pre-close was a result of the esheath entering the vessel or the result of the third attempted pre-close device causing the vascular injury.'' per imaging evaluation, tortuosity was present in the access vessels near the access site.Therefore, it is possible that the sheath interfered with the closure device due to being subjected to the access vessel bend.Available information suggests that patient factors (tortuosity) may have contributed to the complaint event.However, a definitive root cause is unable to be determined at this time.

Manufacturer Narrative

Medical records received regarding this event.New information added to b4, b5, b7, g6, and h2.Investigation is ongoing.

Event Description

As reported by the clinical specialist, during a tf tavr case while removing the esheath the team was on unable to get control of bleeding/hemostasis.A third pre-close device was attempted unsuccessfully.The team determined that the pre-close devices failed and made a decision to perform a successful surgical repair of the artery and deployed two self-expanding stents.The heart team was not sure if the failed pre-close was a result of the esheath entering the vessel or the result of the third attempted pre-close device causing the vascular injury.The patient remained stable per medical records received, under mac anesthesia, patient had a 26mm s3ur implanted via right transfemoral approach.Post-deployment aortogram confirmed correct positioning.Proper valve placement, orientation, and degree of regurgitation was evaluated by tte.The operators were satisfied with the result and equipment was withdrawn.Closure of the right arteriotomy was attempted with 2 percloses, however, there was brisk bleeding at the arteriotomy.A third perclose was deployed but it did not control the bleeding.A 10 fr sheath was inserted into the arteriotomy, and the bleeding continued around it.An angiogram performed from the 10 fr sheath showed brisk bleeding at the arteriotomy but no injury to the iliac artery.The sheath was upsized to a 12 fr with slowed the bleeding down.An occlusive balloon was then used in the distal aorta to control the bleeding.The patient was converted to surgery.As reported by the fcs, the ''heart team'' was not sure if the esheath entering the artery contributed to the percloses failing or if the third perclose attempt contributed to the vascular injury.The medical records did not confirm a negative device interaction but did not provide a cause of the perclose failure.

• 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: 17289387
• MDR Text Key: 318746443
• Report Number: 2015691-2023-14485
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)240224(11)2202242164964420
• 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,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2024
• Device Model Number: 914ESPA
• Device Lot Number: 64964420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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: Female