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

Model Number	916ESA
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the implantation of a 26mm sapien 3 valve in the aortic position patient tortuosity caused for an increased push force for the crimped valve to go through the esheath.The valve delivered normally, but on trying to remove the delivery system, the sheath was split and the ds and sheath had to be removed as a unit.Completion angio shows no disruption to right iliac, femoral, or access site.Patient seemed to be unaffected by this procedure.
Additional Manufacturer Narrative
The investigation is in progress.A supplemental report will be submitted when additional information is provided.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to additional information regarding a liner tear.After further case review as there was no intervention therefore, this event is not reportable.The investigation is ongoing.

• 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: 13546419
• Report Number: 2015691-2022-03987
• Device Sequence Number: 5059997
• Product Code: DYB
• UDI-Device Identifier: 00690103193992
• UDI-Public: (01)00690103193992(17)230621(10)63837778
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K200258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2023
• Device Model Number: 916ESA
• Device Catalogue Number: 916ESA
• Device Lot Number: 63837778
• Was Device Available for Evaluation?: No
• 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: 01/28/2022
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• 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