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

Model Number	914ESA
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Edwards received notification from a field clinical specialist that during a transfemoral tavr, there was difficulty withdrawing the commander delivery system back into the esheath for withdrawal.As reported, post valve deployment, the physician experienced difficulty retrieving ds into sheath tip.The balloon did not rupture during deployment.The physician continued to pull the delivery out of the sheath and the balloon separated from ds shaft on the proximal end.The tip of ds was stuck in esheath hub per fluoro image.The tip of esheath was damaged, it looked like it 'accordioned' back on itself.Per pre-deco evaluation, circumferential delamination 2" in length was found and the c-marker band was present.No adverse events were suffered by the patient.
Additional Manufacturer Narrative
The investigation is in progress.A supplemental report will be submitted.
Additional Manufacturer Narrative
The device was returned for evaluation and an engineering evaluation was performed.The returned device was visually inspected, and the following was observed: three kinks were observed along sheath shaft 2'', 2.5'', and 3'' from distal tip.Circumferential liner delamination 2'' in length was observed from the distal tip.Liner bunching was observed at distal tip of sheath.3mensio imaging was provided and the following was observed: tortuosity was present in patient's access vessels.The device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to this event.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 complaints of sheath liner delamination and sheath distal tip damage were confirmed.A review of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaints.A review of ifu/training materials revealed no deficiencies.As reported, ''post valve deployment, the physician experienced difficulty retrieving delivery system into sheath tip''.Visual inspection of the returned device revealed kinks and circumferential delamination at the distal tip of the sheath.Bunching of the liner was also observed at the distal tip region.It's possible that excessive manipulation was exerted on the delivery system and sheath while attempting to overcome the reported withdrawal difficulties causing the damage and delamination to the distal tip of the sheath.As such available information suggests that procedural factors (withdrawal difficulties, excessive manipulation) may have contributed to the reported event.No labeling, training, or ifu deficiencies were identified.Therefore, no corrective and preventative action nor product risk assessment (pra) is required at this time.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.

• 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: 13261968
• Report Number: 2015691-2022-03407
• Device Sequence Number: 12240525
• Product Code: DYB
• UDI-Device Identifier: 00690103193985
• UDI-Public: (01)00690103193985(17)230506(10)63779121
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K200258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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: 05/06/2023
• Device Model Number: 914ESA
• Device Catalogue Number: 63779121
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• 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: 12/22/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2021
• 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