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

Model Number	914ESA
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
From a clinical study, during the procedure of a 26 mm sapien x4 valve in the aortic position via transfemoral approach, resistance was noted when the delivery system was exiting the sheath.The valve was successfully implanted and there was no vascular injury noted.After esheath removal, the esheath was evaluated the on the back table and found the distal tip of the esheath was fractured/torn.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 investigation conclusions and investigation findings.Added new information to d.9 returned to manufacturer, h.3 device evaluated by manufacturer and h.6 type of investigation.The device was returned to edwards lifesciences for evaluation and the following was observed.Liner fully expanded as designed.Distal tip torn radially along distal edge of liner with hdpe stretching.All score lines present, soft tip damage.Imagery was provided from the site and revealed the following: right vessel dimensions sufficient for 14f esheath (greater than or equal to 5.5mm).Calcification present in the in the vessel including near bifurcation.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaints were confirmed based on evaluation of returned device.However, no manufacturing non-conformances were identified during evaluation of the complaint device.Review of the dhr, lot history, and manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were noted during device unpacking or preparation.As reported, ''from a clinical study, during the procedure of a 26 mm sapien x4 valve in the aortic position via transfemoral approach, resistance was noted when the delivery system was exiting the sheath.The valve was successfully implanted and there was no vascular injury noted.After esheath removal, the esheath was evaluated the on the back table and found the distal tip of the esheath was fractured/torn.'' per evaluation of the returned device, it was confirmed that the distal tip was radially torn.While a definitive root cause was unable to be determined, previous investigation indicated that the tear is attributed to improper tip expansion, resulting in interference between the valve and sheath tip.As such, it is possible that improper tip expansion contributed to distal tip tear.In addition, review of 3mensio revealed presence of calcification in the abdominal aorta.Calcification could also constrain the distal shaft, preventing the tip from opening properly and/or creating torn tip due to increased resistance.As such, the failure mode may be related to improper expansion of the sheath tip during thv advancement and/or patient factors (calcification).However, a definitive root cause is unable to be determined.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 ifu/labeling/training manual inadequacies were identified.A product risk assessment (pra) and a corrective action preventative action (capa) were previously initiated to capture the investigation of these type of events and drive any potential corrective/preventative actions.

• 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: 19768088
• Report Number: 2015691-2024-05436
• Device Sequence Number: 8513520
• Product Code: DYB
• UDI-Device Identifier: 00690103193985
• UDI-Public: (01)00690103193985(17)241004(10)65277019
• 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
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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: 10/04/2024
• Device Model Number: 914ESA
• Device Lot Number: 65277019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/27/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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: Unknown