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

Model Number 916ESPA

Device Problems Peeled/Delaminated (1454); Material Puncture/Hole (1504); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress, a supplemental report will be submitted.

Event Description

Edwards received notification from a field clinical specialist that during a transfemoral tavr, there was resistance between a 29mm s3 valve/delivery system and the 16fr esheath plus.As reported, the valve was advanced with some resistance up to the left iliac at the bifurcation.There was some calcium in the 3mensio report was noted.The team was unable to advance beyond that point.The system was removed together as a unit with the esheath, however it was only able to back out the system slightly.They continued to remove the devices together but had some resistance and then "felt a pop." the patient's blood pressure dropped, and a vascular surgeon was called to repair the perforation.Cpr was started and the coda balloon was placed.The vascular surgeon arrived, and requested that the system be removed.A new 16fr esheath was inserted.Repair of the left iliac was in progress while cpr continued with a full code.Blood products were given but the patient did not recover.The patient expired after approximately one hour of resuscitation attempts.Per pre-deco evaluation of the esheath, the liner torn was torn, a liner strand was observed, and a small hole in the hdpe was noted.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The following observations were seen on the returned sheath: the liner was torn starting 8'' from the comnut, approximately 3'' in length.A liner strand was present at 4'' from distal tip, approximately 2.5'' in length.Distal 3'' of the liner was not expanded.Liner lifting was present in the region 1-2'' from distal tip.Sheath shaft damages were observed in the region where the valve was stuck: the hdpe portion was folded inward.The sheath shaft was punctured.Scratches were noted on the sheath shaft.The device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating 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 the failure mode is not required at this time.The complaints of resistance between system components, sheath liner torn, sheath liner strand, and sheath punctured were confirmed from the product evaluation: however, as the devices met specification, no manufacturing non-conformances were identified in the evaluation.Review of the dhr, complaint history, and lot history showed no indication a manufacturing non-conformance contributed to the event.No ifu/training manual deficiencies were identified.As reported, ''the valve was advance with some resistance up to the left iliac at the bifurcation.Some calcium in the 3mensio report was noted.The team was unable to advance beyond that point''.3mensio confirmed the presence of calcification in the vessel and is corroborated by the presence of scratches on the returned sheath.3mensio also showed the presence of tortuosity.Per the ifu/training manual, ''push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification.'' tortuosity can create sub-optimal angles leading to non-coaxial delivery system advancement.Calcification can reduce the vessel lumen diameter and create a constrained condition, resulting in difficulty during the advancement of the delivery system.Additionally, sharp calcified nodules can weaken the liner making it susceptible tearing during advancement.Calcification compounded with non-coaxial advancement can lead to increased friction between the valve and weakened sheath, tearing the liner.Bent struts present on the crimped valve further supports this interaction.The bent struts likely interacted with the shaft as well resulting in the shaft puncture.Available information suggests patient (calcification, tortuosity) and/or procedural factors (valve strut caught on liner/sheath, bent valve strut) contributed to the events.No ifu/training manual deficiencies were identified.Therefore, no corrective action nor product risk assessment (pra) is required at this time.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.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2022-07328.

• 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: 15226046
• MDR Text Key: 305073325
• Report Number: 2015691-2022-07327
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)240120(11)2201202164190940
• 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: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2024
• Device Model Number: 916ESPA
• Device Catalogue Number: N/A
• Device Lot Number: 64190940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 10/28/2022
• Supplement Dates FDA Received: 10/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 76 YR
• Patient Sex: Male