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

Model Number 9610ES16

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation ongoing.

Event Description

As reported by our affiliates in (b)(6), while inspecting the 16fr esheath post procedure, it was seen that the tip damaged and there was a strand of sheath material.There were no problems during device insertion or removal.Devices were prepared as per ifu and the valve was implanted without any issues. final angiography was good and the patient was in good condition post procedure.

Manufacturer Narrative

Additional finding from visual inspection of the returned esheath: hdpe and soft tip damage at the distal tip of device.  observations from review of photographs provided by the site showed: access vessel was tortuous.Liner tear, distal tip damage, and sheath shaft damage was noted on the complaint device.During dimensional testing the liner thickness was measured along the length of tears.The liner thickness was found to be within specification at all measurement locations.  due to the condition of the returned device and nature of the issue, no relevant functional testing was performed.A device history records (dhr) review did not reveal any manufacturing non-conformance that would have contributed to this complaint event.  a lot history review revealed no additional similar complaints.A review of the complaint history from (b)(6) 2018 to (b)(6) 2019 other returned similar complaints.  no manufacturing non-conformities were found in the returned samples.Available information suggests that patient and procedural factors (i.E.Access vessel diameter, calcification/tortuosity; sheath not fully inserted; withdrawal of burst or torn balloon; advancing the stiff end of guidewire through sheath), may have contributed to the similar events.A review of complaint history revealed that the monthly occurrence rate did not exceed the control limit for the trend category.  per the ifu and training manuals review: this product is contraindicated for patients with tortuous or calcified vessels that would prevent safe entry of the dilators and esheath.The esheath temporarily enlarges to allow the passage of devices; ensure that the vasculature can accommodate the maximum diameter of the expanded sheath.  when inserting, manipulating or withdrawing a device through the esheath, always maintain orientation of the sheath position.Insert slowly with continuous motion to minimize friction.Suture the esheath into place.After the completion of the procedure and removal of the device, remove the suture, and then remove the esheath entirely without torquing and do not reinsert.  do not force sheath.The appropriate esheath size should be used based on the minimum access vessel diameter.  the access vessel minimum luminal diameter (mld) recommended for a 16f esheath with a commander delivery system is 6.0mm.  no ifu/ training deficiencies were identified.During manufacturing, the esheaths undergo 100% final inspection by manufacturing and quality.Additionally, all manufacturing lots are subject to product verification (pv) testing on a sampling basis, including sheath expansion testing after sterilization.All samples passed product verification testing for this work order.The inspections and tests described above support that it is unlikely a manufacturing non-conformance contributed to the reported complaint.  the complaints for sheath shaft damaged and sheath distal tip damaged, were confirmed based on the returned condition of the device.Visual inspection revealed the sheath liner was torn.However, no manufacturing non-conformances were identified in the returned device.A review of the dhr, lot history, complaint history, and manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.Additionally, a review of the ifu and training manual revealed no deficiencies.The scratches observed in the sheath shaft and the soft tip damage would indicate that the patient access vessel has calcification.Information regarding the access vessel was provided and was found to be tortuous.  sheath liner tears have been previously investigated by edwards and documented in a technical summary.  relevant complaint data and the summary of the associated engineering evaluations of returned devices performed from (b)(6) 2015 to (b)(6) 2016 are aggregated in this technical summary.Liner tears can occur at some point during expansion of the esheath either during insertion or retrieval of a delivery system or balloon catheter.The length of the liner tear can vary, with lengths spanning small portions of the sheath shaft or across the entire length.This technical summary outlines the current mitigations during the manufacturing process (i.E.Visual inspections and functional evaluations) and in the instructions for use (ifu) and training documents.Based on available evaluation data, clinical input and complaint report trending, the information summarized in this technical summary supports that the sheath liner tear occurring during the use in the patient have had root causes related to patient factors (tortuous patient anatomy/peripheral vessel calcification) and/or procedural factors (non-coaxial retrieval, incomplete deflation) rather than a device non-conformance.  interaction with calcification upon sheath insertion into a tortuous/calcified access vessel can damage the hpde (blue) material along the shaft, causing strands and distal tip damage.  based on available information, a definitive root cause could not be determined at this time.However, available information suggests that patient (access vessel calcification and tortuosity) factors likely contributed to the reported events.Since no product non-conformances or ifu/ labeling /training deficiencies were identified, and the monthly occurrence rate did not exceed the control limit for the trend category, neither a product risk assessment escalation, corrective or preventative action is required.

Manufacturer Narrative

Supplemental report to indicate the device return.There was  a liner tear 5.75" in length from distal tip.A liner strand starting 1.25" from distal tip, strand is approx. 0.5" in length, strand leads into deep.Scratch in hdpe that runs along the full length of shaft liner has a tear approximately 0.5" in length, starting 1" from distal tip.Investigation is ongoing.

Manufacturer Narrative

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

• Brand Name: EDWARDS EXPANDABLE INTRODUCER SHEATH SET
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8677009
• MDR Text Key: 147953380
• Report Number: 2015691-2019-02050
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2021
• Device Model Number: 9610ES16
• Device Lot Number: 61996418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR