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

Model Number	14000ES16A
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field clinical specialist (fcs), during implant of a 29mm sapien 3 ultra resilia valve in the aortic position via right transfemoral approach, it's noted there was some resistance while advancing the delivery system with crimped valve through the 16f optima sheath due to a kink in the optima as well as a small puncture from the patient's tortuosity of the right iliac.The delivery system was able to be pulled out of the sheath.There were no patient injuries.The valve was implanted successfully, and the patient was in stable condition.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
A supplemental mdr is being submitted to correct the previously reported event.Based on the engineering pre decontamination evaluation of the returned complaint device, no sheath shaft damage was identified; only a puncture on the outer jacket was observed.The 16f esheath optima was received with the introducer fully inserted and locked.Curvature of the sheath shaft was noted and is likely attributable to packaging.One kink was observed approximately 7.25" from the distal tip, and a puncture on the outer jacket was identified at approximately 8.2" from the distal tip.Multiple tents were also noted along the sheath shaft.The distal tip functioned as intended.During flushing, no leakage was observed from the outer jacket puncture.Engineering subsequently peeled back the outer jacket, confirming that the inner membrane remained intact with no punctures.The observed 'hole' in the outer jacket corresponded with the area of inner member tenting.Based on the information available at this time, the findings do not indicate an esheath+ malfunction, use error, or patient injury.Tenting is not considered a device malfunction and is not expected to pose a risk for vascular injury, as it is transient, non mobile, and demonstrates minimal interaction with the vessel.Therefore, this event is no longer considered an fda reportable malfunction.

• Brand Name: EDWARDS ESHEATH OPTIMA 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: 23742505
• Report Number: 2015691-2025-09824
• Device Sequence Number: 21419919
• Product Code: DYB
• UDI-Device Identifier: 00690103220636
• UDI-Public: (01)00690103220636(17)260303(11)250902
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K244046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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 Expiration Date: 03/03/2026
• Device Model Number: 14000ES16A
• Device Lot Number: 66971567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2025
• 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 Age: 68 YR
• Patient Sex: Male