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

Model Number 9610ES14

Device Problem Material Integrity Problem (2978)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 09/22/2022

Event Type  Injury  

Event Description

As reported by our affiliates in (b)(6), this was a 26mm sapien 3 ultra case by transfemoral approach in aortic position.Due to heavy calcification in the right groin near the abdominal aorta, it was not possible to cross with the esheath.It was tried with several dilatations, shockwave, and different maneuvers but it was not possible to cross.In total, 3 or 4 esheaths were used and all of them damaged while attempting to introduce them.After placing a peripheral stent because of some bleeding, it was decided to abort the procedure to discuss alternatives.Further procedure by transapical approach was planned, but the patient died on the same evening due to cardiac failure.According to the physician, the bleeding was close to the access site, but it is unknown what caused the bleeding.The most likely reason was the difficult trial to open the calcification and use many sheaths, wires, balloons, etc.The patient had a long-lasting failing case with complications in the groin, the patient needed blood transfusion, and had issues with low pressure problems several times.Cause of patient's death was cardiac failure.The esheath was not the reason for the patient's death.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

Updated h6-type of investigation, investigation findings corrected h6- investigation conclusions the device was not returned for evaluation.The complaint for damaged sheath was unable to be confirmed without procedural imagery or the returned device.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.Dhr and lot history did not reveal any manufacturing non-conformance.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issues with the sheath during device preparation or unpacking, indicating that this was not an out of the box issue.A review of edwards lifesciences risk management documentation was performed for this case.The reported events are an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure modes are not required at this time.Per complaint details, "due to the heavy calcification in the right groin near the abdominal aorta, it was not possible to cross with the esheath.It was tried with several dilatations, shockwave, different maneuvers but it was not possible to cross.In total, 3 or 4 esheath were used and all of them damaged (all kinked, one split at the liner but not opened) while attempting to introduce them.The bleeding was close to the access site and it is unknown what has caused the bleeding- most possible reason was the hard trial to open the calcification and use many sheaths, wires, balloons, etc." per the ifu/training manual, "system advancement force can vary due to angle of access and insertion, vessel diameter, tortuosity and degree of calcification." heavy calcification can present a barrier in introducing the sheath as well as reducing the vessel lumen diameter.In order to overcome the calcification, excessive manipulation was likely used.Excessive manipulation could have caused the sheath to become kinked, as reported.Additionally, although it is not known what the exact damage to the sheath is, the sheath tip can become damaged through contact with sharp calcified nodules.The liner can also become weakened and shaft body can be damaged through contact with calcification.As such, available information suggests that patient factors (calcification) and/or procedural factors (excessive manipulation) may have contributed to the complaint event.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 Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15591003
• MDR Text Key: 301628075
• Report Number: 2015691-2022-08537
• 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: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610ES14
• Device Catalogue Number: N/A
• Device Lot Number: 64423129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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 Age: 82 YR
• Patient Sex: Male