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

Model Number	916ESPA
Medical Device Problem Codes	Material Puncture/Hole (1504); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be completed upon completion.This is one of two manufacturer reports being submitted for this case.
Event or Problem Description
Edwards received notification from a field clinical specialist that a patient underwent right side transfemoral tavr.As reported, during the 1st attempt, upon entering the 29mm sapien 3 ultra resilia valve into the 16fr esheath+, there was resistance noted at the femoral head and the 29mm commander system was unable to be advanced.A tine was seen "bowing" on fluoroscopy and at this point the system and sheath was removed as a unit.The delivery system did and valve did not exit the tip of the sheath.The sheath had a visible what appeared to be a perforation with a strut just at the beginning of the blue portion.A new 16fr esheath+/29mm commander/29mm s3ur valve were prepped in standard fashion and implanted.On the second attempt there was a little resistance but delivery system was able to track and procedure completed.On removal of the second sheath the tip was noted to be torn.Per the field clinical specialist, the damage was consistent with sheath distal tip damage.There was no withdraw difficulty noted.Angiogram after implant showed no vascular injury per the interventional cardiologist.The original commander/ sheath/ valve system will be returned; the second sheath will also be returned.The perceived root cause of the event was unknown but possibly calcium/vessel tortuosity.

• Brand Name: EDWARDS ESHEATH+ INTRODUCER SET
• Common Device Name: 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: 25143068
• Report Number: 2015691-2026-15079
• Device Sequence Number: 18505255
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)271218(11)251218
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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
• Operator of Device: Health Professional
• Device Model Number: 916ESPA
• Device Catalogue Number: N/A
• Device Lot Number: 67299634
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male