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

Model Number 9610ES16

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

Patient Problem Unspecified Vascular Problem (4441)

Event Date 05/30/2022

Event Type  Death  

Event Description

Edwards received notification from our affiliate in germany.As reported, this was a case of an implant of 29mm edwards sapien 3 transcatheter heart valve, in the aortic position by transfemoral approach.The patient presented with tortuous vessels and some calcifications at common femoral artery (cfa) and right external iliac artery.When advancing the commander delivery system, very high push force was encountered and no advancement was possible.On fluoro, exposure of the valve through the liner (torn) was observed.Bail out maneuvers were attempted but there was no chance to remove the device without causing vascular injury (the device did not cause direct damage to the patient).Therefore, the decision was to surgically remove the devices.The patient received 4 blood transfusions during surgery and the patient expired overnight due to sequelae of hemorrhagic shock.

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be completed upon completion.Device was discarded.

Manufacturer Narrative

The device was not returned for evaluation as it was discarded.Therefore, a no product return engineering evaluation was performed.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 sheath liner punctured and resistance between system components were confirmed based on provided imagery.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.Reviews of the lot history, dhr, and complaint history showed no indication a manufacturing non-conformance contributed to the event.No ifu/training manual deficiencies were identified.As no damages on the sheath were observed or reported during device preparation, the liner damage was likely not present out of the packaging.As reported, ''the patient presented tortuous vessels and some calcifications at cfa and right external iliac artery, lunderquist guidewire was used to straighten out the anatomy.During procedure, no issues were found when inserting the 16fr esheath.But when advancing the commander ds very high push force encountered, no advancement possible, on fluoro it was observed exposure of the valve through liner (torn)''.Per imaging evaluation, the crimped valve and delivery system were observed to be non-coaxial while punctured through the sheath.Per the ifu/training manual, ''push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification''.Per complaint description, tortuosity and calcification in the patient's access vessels were noted.Tortuosity can lead to non-coaxial alignment between the delivery system with crimped valve and sheath inner lumen, which may have led to the experienced resistance.Calcification can reduce the vessel diameter and may increase restriction leading to resistance.Calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.During the experienced difficulty, it is also possible that excessive manipulation may have been applied, which could have led to the noted protrusion of the delivery system and crimped valve through the liner.Available information suggests patient (tortuosity/calcification) and/or procedural (excessive manipulation) factors contributed to the event.No ifu/training manual deficiencies were identified.No corrective/preventative action nor pra escalation are 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.

• 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: 14847530
• MDR Text Key: 294902794
• Report Number: 2015691-2022-06433
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2024
• Device Model Number: 9610ES16
• Device Catalogue Number: N/A
• Device Lot Number: 64198562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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; Death
• Patient Sex: Male