MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER SET

Model Number	916ESA
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a tf tavr case the team had trouble with balloon alignment with first system.They attempted balloon alignment, performed in the straight portion of the aorta.The reset the alignment knob.Pulled negative on the balloon with the atrion.The team could not get the valve to go back in the sheath to remove from the body.Eventually it appeared to have successfully retracted the valve frame into the esheath.Pulled unit out as one but valve stripped off the delivery system into the soft tissue of the access track from the skin surface to the artery.The vessel had been damaged severely from the laceration from the valve becoming stuck in the tissue track that the 16 fr e-sheath was just too small to seal the hole in the vessel.Replacement with 16f esheath did not achieve hemostasis.Used a 24f dry seal with good hemostasis.Second system was prepped and valve alignment without complication and implanted without complication.Surgical cut down to repair the right femoral artery after the injury from the embolized 29 mm valve.System is available to return.Vascular repair performed by vascular surgeon at the end of the case with successful repair of the cfa.Patient tolerated the procedure well.Planned hospital discharge.A split in the distal tip of the was noted after it was removed from the patient.
Additional Manufacturer Narrative
This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2022-03487.Investigation is ongoing.
Additional Manufacturer Narrative
This event was previously reported by edwards lifesciences under manufacturer report # 2015691-2022-03490.Additional information obtained through pre-decontamination of the returned sheath and further confirmation with the field team clarified that the distal tip of the sheath was not actually split, as previously indicated.Based on these results, this complaint is no longer considered to be a reportable event and a corrected report is being submitted.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Common Device Name: EDWARDS ESHEATH INTRODUCER SET
• 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: 13297350
• Report Number: 2015691-2022-03490
• Device Sequence Number: 3284051
• Product Code: DYB
• UDI-Device Identifier: 00690103193992
• UDI-Public: (01)00690103193992(17)230706(10)63880130
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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: 07/06/2023
• Device Model Number: 916ESA
• Device Lot Number: 63880130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• 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: 12/28/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 02/04/2022
• Date Device Manufactured: 07/06/2021
• 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