MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SHEATH INTRODUCER SET; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number TF SHEATH UNK

Device Problems Separation Failure (2547); Free or Unrestricted Flow (2945)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

Voluntary medwatch no.Mw058620.Investigation is ongoing.

Event Description

As received through a voluntary medwatch, during a tavr procedure, the valve had been deployed and the delivery system was being removed, upon removing the system through the sheath, the sheath's hemostatic valve was ¿compromised¿ allowing free bleeding through the sheath.Direct pressure was held, and the sheath was removed.There was no report of patient injury or blood transfusion.No additional information will be provided.There was no information on the hospital or implant physician.

Manufacturer Narrative

The sheath was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.A device history record (dhr) and a lot history review could not be performed as the lot number was not provided.A review of complaint history from june 2018 to may 2019 for the edwards axela sheath (all models, sizes) and the edwards esheath (all models, sizes) revealed no other similar complaints.   the complaint history review revealed that the occurrence rate for the trend category did not exceed the may 2019 control limits.Review of manufacturing mitigations was against the procedures effective during the time of complaint occurrence, which are representative manufacturing steps taken at the time.Per procedure for axela sheaths, the outer jacket assembly is visually inspected.The outer jacket loading on the inner member is visually inspected.Per procedure, the proximal end of the shafts is flared and inspected for length.Devices are then 100% visually inspected.Per procedure, following shaft pre-conditioning, the devices are inspected.Per procedure, on the component level, the shafts undergo 100% visual inspection by both manufacturing and quality.During the hemostasis valve assembly per procedure, the valve is visually inspected (both sides) and housing for mechanical damage.Per procedure, the sheath shaft to housing bond is visually inspected.During final inspection, per procedure, the final sheath assembly undergoes 100% inspection by both manufacturing and quality.In addition, each manufacturing lot is required to undergo the product verification (pv) testing under a sampling plan per procedure before final release.These tests included shaft to housing tensile testing.The lot is released if all samples pass pv testing.The inspections described above support that it is unlikely a manufacturing nonconformance contributed to the reported event.During the manufacturing process, the esheath undergoes multiple inspections.The esheaths are visually inspected for any visible damage.During the final inspection, the esheath undergoes 100% inspection by both manufacturing and quality per procedure.After sterilization, sheath expansion testing was performed during product verification (pv) on finished devices from the work order under a sampling basis per procedure.These tests included shaft to housing tensile testing.The lot is released if all samples pass pv testing.The inspections described above support that it is unlikely a manufacturing nonconformance contributed to the reported event.The ifu and training manuals were reviewed for guidance/instruction involving the axela sheath and delivery system usage, the ifu for edwards axela sheath, the ifu for edwards sapien 3 ultra thv system, device preparation manual and edwards sapien 3 ultra procedure training manual. the procedural training manual provides guidance for sheath removal: maintain guidewire position in the aorta, remove the suture securing the sheath, remove the sheath entirely without torquing ensuring the edwards logo is facing upwards and do not reinsert the sheath at any time during removal.The esheath ifu, commander ifu, device preparation manual, and the training manual were reviewed for device preparation and use instructions.The procedural training manual for the esheath introducer set provides guidance on sheath removal: remove the suture securing the sheath, remove the sheath entirely without torquing ensuring the edwards logo is facing upwards, do not reinsert the sheath at any time during removal, the hemostasis will not be maintained if the sheath is partially removed past the partially expandable section and have an appropriate dilator ready to occlude the vessel if required.No ifu or training deficiencies were identified for either device.The complaint for was unable to be confirmed as the device and applicable imagery was not provided.Review of the dhr and lot history was unable to be performed as the work order information was not provided.Complaint history and manufacturing mitigations provided no indication that manufacturing nonconformance was a contributing factor.A review of ifu/training materials revealed no deficiencies.As reported the ¿the sheath's hemostatic valve was compromised¿ during delivery system removal.Since sheath hemostasis was not reported to be compromised prior to delivery system removal, it is likely that procedural factors contributed to the complaint event.It is possible that excessive manipulation of the delivery system and/or guidewire with the sheath during delivery system removal potentially contributed to damage to the sheath housing/hemostatic valves.In this case, it is possible that procedural factors (excessive manipulation) may have contributed to the reported event.However, a conclusive root cause is unable to be determined at this time.No labeling inadequacies and no manufacturing nonconformances were identified during evaluation.Review of complaint history did not exceed the monthly trigger for action (for the axela sheath) or monthly control limits (for the esheath).Therefore, no corrective or preventative action is required.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS SHEATH INTRODUCER SET
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8710058
• MDR Text Key: 151741771
• Report Number: 2015691-2019-02209
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: 140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TF SHEATH UNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1