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

Model Number 916ESP

Device Problems Difficult to Insert (1316); Peeled/Delaminated (1454); Material Puncture/Hole (1504)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 08/16/2022

Event Type  Death  

Manufacturer Narrative

Investigation is ongoing.

Event Description

During a tavr procedure using a 29mm sapien 3 valve via transfemoral approach, the operator lost wire access to the left ventricle (lv).The operator attempted to recross but were unsuccessful, and the system was removed and prepped a 2nd device.Upon insertion of the 2nd valve system, the patient's pressure dropped to 40/20 when a perforation occurred at the distal aorta just above the iliac bifurcation.Information received from the sales director indicated that there was an island of calcium at the aortic perforation site.The perforation was possibly due to the insertion of the esheath and the 2nd delivery system and valve being advance through the sheath, impacting on the island of calcium.The operators attempted to pull the delivery system out of the esheath, but they pulled the crimped valve off of the balloon and it remained stuck in the mid portion of the sheath.The patient ultimately expired on the table after 25 minutes of cpr and discussion with vascular surgery on whether or not to attempt a vascular salvage (declined).

Manufacturer Narrative

Correction to h6; component code, device code, type of investigation, investigation findings, investigation conclusion.Update to d4- model number added.Although the device was expected to be returned, the hospital risk management department has not released the device for evaluation.The 16 fr esheath plus was not returned to edwards lifesciences for evaluation; therefore, no visual inspection, functional testing, and dimensional testing are applicable.A photograph of the esheath was provided and the sheath liner appears torn at the middle of the shaft and the hdpe had damage in that region.The liner appears otherwise expanded as designed.The esheath+ ifu, commander delivery system ifu, and device and procedural preparation manual instructions for use (ifu) were reviewed.The device preparation manual provides guidance on vascular access.Access characteristics that would preclude safe placement of the sheath such as severe obstructive calcification, severe tortuosity, or vessel diameters less than the minimum recommended (less than 5.5 mm or 6 mm) should be carefully assessed prior to the procedure.Based on this review, no ifu training deficiencies were identified.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.The complaints for sheath liner torn and sheath punctured were confirmed from the imaging evaluation, while the complaint of difficulty introducing the sheath was unable to be confirmed.As the lot number was not provided, reviews of the dhr and lot history were unable to be performed.Without the returned device, no testing could be performed; therefore, no manufacturing non-conformance could be identified.A review of the complaint history showed no indication of a manufacturing non-conformance contributed to the event.No ifu/training manual deficiencies were identified.Furthermore, no abnormalities were reported during device unpacking or preparation.As described, "resistance was felt while inserting the esheath+ into the patient, and the tip of the sheath was hitting the lateral aspect of the abdominal aorta proximal to iliac artery bifurcation.There was an island of calcium at this site, and the operator was unable to guide the tip of the esheath around into its final position in the abdominal aorta".An "island of calcium" can induce friction on the sheath during attempts to navigate past.Several factors could have contributed to the damage observed.As reported, "only 1 sheath was used on this procedure".The first delivery system was removed through the sheath, whereas the training manual states during thv retrieval through the sheath, "withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position".Excessive re-use of the sheath during multiple attempts at guidewire replacement, multiple delivery system introduction, and coda balloon intervention, could have contributed to the damage on the sheath throughout the procedure.The ifu states, "the devices are designed, intended, and distributed for single use only".The presence of the "island of calcium" could weaken the sheath liner resulting in the liner tear.Also reported, "the operator pulled the delivery system too fast through the esheath causing the crimped valve to move of the delivery systems balloon and was stuck in the mid-portion of the esheath".The forceful removal of the delivery system within the sheath likely caused the shaft damage and contributed to the liner tear as the valve struts likely caught onto the shaft and liner.In this case, available information suggests the following contributed to the events: patient factors (calcification) contributed to the difficulties in introducing the sheath.Patient factors (calcification), procedural factors (excessive manipulation, withdrawal of crimped valve), and use error (sheath re-use) contributed to the liner tear.Procedural factors (excessive manipulation, withdrawal of crimped valve) and use error (sheath re-use) contributed to the shaft damage.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.

• 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: 15396023
• MDR Text Key: 299657461
• Report Number: 2015691-2022-07813
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 916ESP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2022
• 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): Death
• Patient Sex: Male