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

Model Number	916ESA
Medical Device Problem Codes	Material Separation (1562); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of two manufacturer reports being submitted for this case.The investigation is ongoing.
Event or Problem Description
As reported by research & development (r&d), during testing, a 16fr esheath tore at the distal tip as the 29mm x4 delivery system with crimped 29mm sapien x4 valve passed through the tip.The esheath also exhibited separation of the tip which was found to be attached to the crimped valve.
Additional Manufacturer Narrative
A supplemental mdr is being submitted to include additional information.This is one of two manufacturer reports being submitted for this case.Please reference manufacturer report no: 2015691-2023-10685.The investigation is still ongoing.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for correction and includes additional information based on device evaluation.The following sections of this report have been corrected/updated: h3 (device evaluated by manufacturer), h6 (type of investigation, investigation findings, investigation conclusions) and h10 (provide narrative/data).The device was provided by research & development (r&d) for further evaluation.The device was visually inspected.Visual inspection revealed the liner was fully expanded and the distal tip was torn radially along the distal edge of the liner and separated.All score lines were noted to be present.Imagery was also provided for review.Imagery review revealed the distal tip tore radially and was separated.The separated portion was found on a valve strut.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the events.A lot history review was also performed and it did not provide any indication that a manufacturing non-conformance would have contributed to the events.During manufacturing, the device undergoes multiple 100% inspections.In addition, the work order underwent functional product verification testing on a sampling basis as a requirement for lot release.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported event.The instructions for use (ifu)/training manuals were reviewed for guidance/instruction involving the esheath usage.Based on the review of the ifu/training manuals, no deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The events for esheath distal tip torn and system components separating during use were confirmed per evaluation of the returned device.However, no manufacturing nonconformance was identified during evaluation.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the events.A review of the manufacturing mitigations supports that the esheath has proper inspections in place to detect issues related to the events.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were noted during device unpacking or preparation.Per the event description, "during testing, a 16fr esheath tore at the distal tip as the 29mm x4 delivery system with crimped 29mm sapien x4 valve passed through the tip.The esheath also exhibited separation of the tip which was found to be attached to the crimped valve." per evaluation of the returned device, the esheath distal tip was observed to be torn radially along the distal edge of the liner with the torn section separated.The failure mode is characteristic of sheath tip tear events as described in a previously performed product risk assessment (pra).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 led the distal tip to catch onto the valve while advancing through.As the valve is pushed past the distal tip, the torn portion that is caught onto the valve can separate.In this case, a definitive root cause was unable to be determined; however, the failure mode may be related to improper expansion of the sheath tip during transcatheter heart valve (thv) advancement and/or procedural factors (valve caught on sheath) may have contributed to the events.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.A previous corrective and preventive action (capa) was initiated for this type of event.Additionally, a previous product risk assessment (pra) was performed for this type of event.Further assessment revealed the control limits have not been exceeded.Therefore, no corrective or preventative actions are required at this time.

• 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: 16326552
• Report Number: 2015691-2023-10684
• Device Sequence Number: 15614608
• Product Code: DYB
• UDI-Device Identifier: 00690103193992
• UDI-Public: (01)00690103193992(17)240615(10)64546030
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2023

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: Other
• Device Expiration Date: 06/15/2024
• Device Model Number: 916ESA
• Device Catalogue Number: 916ESA
• Device Lot Number: 64546030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• 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: 01/18/2023
• Supplement Date Received by Manufacturer: 02/08/2023; 04/17/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/02/2023; 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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