MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS AXELA INTRODUCER SET, 14FR; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9630ES14

Device Problems Material Separation (1562); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by our (b)(6) affiliate, after a 23 mm sapien 3 ultra transfemoral case the axela sheath was in 2 pieces.The portion with hemostatic seals and the body of the sheath were separated.There was no impact to the patient.

Manufacturer Narrative

The axela 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.No imaging or photos were provided.During manufacturing, the device and its components were inspected/tested a number of times.After shaft proximal end bonding, the devices are 100% visually inspected.Following inner tip bonding, devices are 100% visually inspected.The inside of the shafts is also 100% visually inspected.During outer jacket assembly the strain relief bond is visually inspected.The outer jacket is visually inspected for wrinkles, holes, and tears.The proximal end of the shafts is flared and inspected for length.Devices are then 100% visually inspected. following shaft pre-conditioning, the devices are inspected.On the component level, the shafts undergo 100% visual inspection by both manufacturing and quality.During sheath shaft to housing bond the devices are inspected and testing several times.The proximal strain relief is visually inspected for damage.During axela sheath final inspection, the assembled devices are inspected for any damage and the hub is visually inspected for damage.In addition, the lot undergoes product verification (pv) testing on a sampling basis.This testing included an insertion force test, peak insertion measured through the shaft and at the tip.In addition, the shaft to housing bond tensile is tested.The lot passed the criteria.These inspections indicate that the sheath has enough inspections in place to identify non-conformances related to the complaint events.The device history record (dhr) review was performed and did not reveal any manufacturing non -conformances that could have contributed to the reported event.A lot history review was performed and revealed no additional complaints for the complaint.A review of complaint history from (b)(6) 2018 through (b)(6) 2019 revealed returned complaints for the axela sheath.The complaints were reviewed based on similar reported events and associated root causes/evaluation codes.No manufacturing non-conformances were identified during the investigations of the similar complaints.  available information suggests that procedural factors may have contributed to the event.A review of complaint history revealed that the occurrence rate did not exceed the (b)(6) 2019 control limit for all the trend categories.The ifu for axela ifu, edwards sapien 3 ultra device preparation manual, and edwards sapien 3 ultra procedural training manual were reviewed for instructions involving device preparation and use. the axela ifu provides directions for use prior to insertion of the sheath into the patient.Inspect the length of the dilators and sheath for surface defects and damage prior to clinical use, orient the sheath appropriately and maintain orientation for the duration of the procedure, insert the sheath assembly beyond the proximal end of the insertion marker to maintain hemostasis and use standard technique while following its progression on fluoroscopy.Note:  do not use if the sheath is damaged (i.E.Kinked or stretched).  do not flush sheath with either dilator or delivery system inserted.  additional considerations: always observe fluoroscopy during insertion.  proper screening is critical to reduce vascular complications.  know position of the sheath tip in the aorta. push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification. perform shallow stick/puncture so that sheath is parallel to leg.  do not force sheath. if having trouble inserting sheath, remove the sheath and try predilating the vessel with a dilator or making the incision larger.  check to ensure sheath is not damaged prior to reinserting.If damaged, return and replace with a new sheath.There were no ifu/training deficiencies identified.The complaint for was unable to be confirmed due to unavailability of the device and lack of imagery provided.Review of the dhr, lot history, complaint history and manufacturing mitigations provided no indication that manufacturing nonconformance was a contributing factor.A review of ifu/training materials revealed no deficiencies.Based on review of similar complaints excessive manipulation applied to overcome resistance felt during the procedure may have led to the sheath housing separation.However, due to unavailability of device and lack of imagery, the exact root cause was unable to be determined at this time and multiple factors may have contributed to the complaint.In this case, available information suggests that procedural factors (excessive manipulation) may have contributed to the reported event.However, a definitive root cause is unable to be conclusively determined.Review of the dhr, lot history, complaint history and manufacturing mitigations provided no indication that manufacturing nonconformance was a contributing factor.A review of ifu/training materials revealed no deficiencies.A capa was initiated to investigate and determine potential root cause and associated corrective and preventive actions as necessary for these types of complaints.  a product risk assessment has been previously initiated to assess product and clinical risk related to this event.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS AXELA INTRODUCER SET, 14FR
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8897417
• MDR Text Key: 195274403
• Report Number: 2015691-2019-03032
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2020
• Device Model Number: 9630ES14
• Device Lot Number: 61772867
• 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