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

Model Number 914ESJ

Device Problem Physical Resistance (2578)

Patient Problem Vascular Dissection (3160)

Event Date 05/22/2018

Event Type  Injury  

Manufacturer Narrative

Investigation is underway.

Event Description

As reported by an edwards lifesciences affiliate in (b)(4), during a transfemoral tavr, a 14fr esheath was inserted smoothly.When the physician inserted the delivery system into the sheath, he felt some resistance at the external iliac artery (eia) area but managed to pass through.A 26mm sapien 3 valve was deployed successfully.While removing the sheath, digital subtraction angiography showed a dissection between the common iliac artery to eia.A pta stent was placed.Blood flow was confirmed and the procedure was completed.The physician mentioned that he felt a stronger resistance than usual when advancing the delivery system into the sheath.The access vessel (right external iliac artery [eia]) luminal diameter was over 5.5mm with no calcification and mild tortuosity.

Manufacturer Narrative

Was inadvertently left out for 2015691-2018-02270 follow up 1.The date should have been (b)(6) 2018.

Manufacturer Narrative

The device was not returned for evaluation and imagery, photographs, and videos were not provided for review.A device history review (dhr) was performed and none of the relevant work orders revealed any issues that may have contributed to the reported event.A lot history review was performed revealed no additional complaints for ¿sheath, shaft ¿ resistance with delivery system, bc¿.A review of complaint history reveals that the occurrence rate for sheath shaft resistance with delivery system, bc did not exceed the may 2018 control limits for the trend category ¿resistance between devices¿.No instructions for use (ifu) or training deficiencies were identified.Inspections during the manufacturing process and testing performed during the product verification process support that it unlikely that a manufacturing nonconformance contributed to the reported complaints.Because the device was not returned for evaluation and no imagery was provided for review, the complaint for ¿sheath shaft ¿ resistance with delivery system¿ was unable to be confirmed.A review of complaint history, lot history, and dhr revealed no indication that a manufacturing nonconformance contributed to the complaint events, and a review of manufacturing mitigations further supports that the devices have sufficient inspections in place to identify defects related to the complaint events.A review of the ifu/training materials revealed no deficiencies.Training materials indicate that the insertion force of the sheath and delivery system can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification.The access vessel tortuosity could provide a difficult pathway for delivery system advancement, increasing the resistance during delivery system insertion through sheath.As noted in the reported information, the patient access vessel was mildly tortuous.Additionally a review of past complaint revealed that procedural factors such as angle of insertion, improper flushing/wetting of the devices, incomplete/misaligned valve crimping, and residual fluid left in balloon during preparation could also contribute to resistance during advancement of delivery system through the sheath.As a result, available information suggests patient/procedural factors may have contributed to the reported event.However, a definitive root cause could not be determined at this time.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 complaint was unable to be confirmed, and no training/ifu/labeling inadequacies were identified.No manufacturing nonconformance was identified during evaluation and available information suggests that patient/procedural factors may have contributed to the reported event.Review of complaint history revealed that the occurrence rate does not exceed control limits for this trend category.Therefore, no corrective or preventative action is required.The cause of the iliac artery dissection is also unknown, however, may be due to patient factors (mild tortuosity) and/or procedural factors mentioned above.  the complaint was unable to be confirmed, and no training/ifu/labeling inadequacies were identified.No manufacturing nonconformance was identified during evaluation and available information suggests that patient/procedural factors may have contributed to the reported event.Review of complaint history revealed that the occurrence rate does not exceed control limits for this trend category.Therefore, no corrective or preventative action is required.

Manufacturer Narrative

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

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7597081
• MDR Text Key: 110935955
• Report Number: 2015691-2018-02270
• 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,Followup,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2019
• Device Model Number: 914ESJ
• Device Catalogue Number: N/A
• Device Lot Number: 61033391
• Other Device ID Number: N/A
• 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
• Treatment: N/A.
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR