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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES EDWARDS ESHEATH + INTRODUCER SET; INTRODUCER, CATHETER Back to Search Results
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.
 
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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 Key15226046
MDR Text Key305073325
Report Number2015691-2022-07327
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00690103215472
UDI-Public(01)00690103215472(17)240120(11)2201202164190940
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200258
Number of Events Reported1
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 Date01/20/2024
Device Model Number916ESPA
Device Catalogue NumberN/A
Device Lot Number64190940
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/20/2022
Initial Date FDA Received08/15/2022
Supplement Dates Manufacturer Received10/28/2022
Supplement Dates FDA Received10/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age76 YR
Patient SexMale
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