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

Model Number	916ESA
Medical Device Problem Codes	Difficult to Advance (2920); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during lab testing, there were two cases of a sapien 3 valve catching inside the esheath tip before it exited the sheath.After pushing out, a small blue tip section ripped off.The test involved measuring push out forces of a crimped valve on commander balloon shaft through esheath and out of its tip.Two units saw high forces of 35.34n and 27.26n before the valve exited the esheath.The two units seemed to have a smaller or constricted internal diameter or some anomaly at the tip that may have caused the valve to catch onto the esheath tip before it was pushed out.A total of five units from this same lot were tested.Per additional information received, the valve was crimped then aligned on the inflation balloon.All devices were prepped and tested per protocol.No abnormalities were noted during valve crimping.The valve was coaxial on the delivery system.
Additional Manufacturer Narrative
Investigation is ongoing.
Additional Manufacturer Narrative
Added h6 type of investigation and investigation findings corrected h6 component code and investigation conclusions the returned device was evaluated, and the following was noted: both sheaths were fully expanded, as designed.The tip for both sheaths did not open along the axial score line.Stretching noted throughout distal tips.Distal tip was torn radially along distal end of liner but remained attached to the sheath.All score lines were present.Both valves were received fully expanded with slightly canted frames.Due to condition of the returned devices (distal tip torn), no applicable functional testing was able to be performed.The returned associated crimper was functionally tested, and no abnormalities were observed.Due to condition of the returned devices (distal tip torn), no applicable dimensional testing was able to be performed.The complaints for distal tip torn and sheath resistance were confirmed.A device history review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.The lot history review was performed and revealed no other complaints relating to distal tip torn and sheath resistance.Manufacturing mitigations/controls relevant to the issue support that it is unlikely that a non-conformance contributed to the reported complaint.The complaint event did not occur in patient anatomy, but rather during design verification (dv) testing.The devices were prepared per the procedure.Based on the review, no ifu or training deficiencies were identified.Although the complaints for distal tip torn and sheath resistance were confirmed, a complaint history is not required, as the issue has been previously identified in a product risk assessment (pra) and corrective action preventative action (capa) which captures root cause analysis for the issue.This event reports a distal tip tear during delivery system insertion that has not resulted in a patient harm, or a device failure to perform its function.Also, there was no evidence of product non-conformances or labeling/ifu inadequacies identified in the evaluation.Therefore, it is not included in the risk management file.Edwards continues to monitor complaint history on a monthly basis.A pra was initiated for re-escalation of distal tip tears on the esheath/esheath+ introducer set, as trending analysis indicated complaint rates for the esheath introducer set exceeded the monthly control limit.A capa was previously initiated to pursue potential process improvement activities regarding tip expansion.The complaints for distal tip torn and sheath resistance were confirmed per evaluation of the returned device.However, no manufacturing nonconformance was identified during evaluation.Review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaints.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were noted during device unpacking or preparation.Per the complaint description, "there were two cases of a sapien 3 valve catching inside the esheath tip before it exited the sheath.After pushing out, a small blue tip section ripped off".Per evaluation of the returned device, the sheath distal tip was observed to be torn radially along the distal edge of the liner.The failure mode is characteristic of sheath tip tear events as described in a 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 contributed to the experienced delivery system advancement resistance at the sheath distal tip and the distal tip tear.A valve strut was observed catching on the sheath distal tip.As the sheath distal tip was torn, the inner diameter of the sheath was unable to be measured.As such, the failure mode may be related to improper expansion of the sheath tip during thv advancement.However, a definitive root cause was unable to be determined at this time.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 13581419
• Report Number: 2015691-2022-04090
• Device Sequence Number: 17596729
• Product Code: DYB
• UDI-Device Identifier: 00690103193992
• UDI-Public: (01)00690103193992(17)230907(10)63980932
• 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
• Report Date (Section B): 05/06/2022

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: 09/07/2023
• Device Model Number: 916ESA
• Device Catalogue Number: N/A
• Device Lot Number: 63980932
• Was Device Available for Evaluation?: Yes
• 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: 01/31/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• 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: Unknown