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

Model Number 9610ES16

Device Problems Fluid/Blood Leak (1250); Physical Resistance (2578)

Patient Problem Perforation of Vessels (2135)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is ongoing.

Event Description

As reported by the edwards european affiliate, during a sapien 3 tf tavr case, ¿a perforation of the delivery system by the valve was observed.¿ the delivery system with valve were attempted to be removed but this caused a perforation of the right iliac artery, which required angioplasty.

Manufacturer Narrative

During preliminary evaluation of the returned device, a puncture was observed on the sheath strain relief.The sheath was expanded approximately 4-5cm in length distal from the strain relief, the remainder of the sheath was not expanded.There was minor distal tip damage, the distal tip was not expanded, and scratches were observed along the sheath shaft.One bent strut was observed on the inflow portion of the valve.The investigation is ongoing.After review of the reported events compared to the preliminary evaluation of the returned device, it was determined there was a translation error.A puncture was observed on the sheath, not the delivery system.Corrected udi number: (b)(4).

Event Description

As reported by the edwards european affiliate, during the tavr procedure with a 29mm sapien 3 valve by transfemoral approach, a perforation of the sheath by the valve was noted during the advancement of the commander delivery system and valve through the sheath.As a result, the delivery system and valve could not be advanced.The delivery system, valve, and sheath were attempted to be removed, but this caused a perforation of the right iliac artery, which required angioplasty.

Manufacturer Narrative

The devices were returned to edwards lifesciences for evaluation.During visual analysis it was observed there was a puncture observed on sheath strain relief and valve struts were poking through the shaft, the sheath was expanded approximately 4-5cm in length distal from the strain relief, the remainder of the sheath was unexpanded, there were scratches observed along the sheath shaft, and there was minor distal tip damage.A kink on the sheath approximately 6 cm from the comnut was observed, but was considered to be due to packaging.The delivery system was returned partially flexed, there were gouges on the flex tip, and a loader tube kink was observed in the sheath housing.One bent strut was observed on the inflow portion of the valve.Due to the nature of the complaint and the returned condition of the devices (sheath partially expanded, kinked/bent) no relevant dimensional testing could be performed on the sheath.In order to decontaminate the devices, the delivery system was removed from the loader and sheath.However, due to the kink in the loader and damage to the sheath shaft, the distal end of the delivery system was damaged during removal by engineering.The inflation balloon separated from the crimp balloon and the spring was stretched.The valve was removed from the delivery system.The flex tip was not damaged and represents the largest component to pass through the sheath during insertion.As a result, the distal end of the delivery system was cut, and the remainder of the delivery system was fully inserted through the sheath, with the flex tip intact.The unexpanded portion of the sheath was able to be fully expanded with no abnormalities observed.A review of complaint history suggests that patient or procedural factors may have contributed to the reported resistance.As noted in the training manual, ¿push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification¿.Calcification and tortuosity can contribute to insertion difficulty.Calcification in the access vessel can interact with the sheath and delivery system during insertion and create resistance, while tortuous patient anatomy can create sub-optimal angles that could result in a difficult pathway for advancement of the delivery system.Although no imagery or information was provided of the patient¿s anatomy, visual inspection of the device revealed scratches along the sheath shaft, indicating that calcification was present.In addition, the outward bending strut suggests that tortuosity was likely present during device insertion, causing the valve strut to catch along the liner and protrude through the sheath shaft.Furthermore, the delivery system was returned with partial flex used.If the device was flexed during insertion through the sheath, this would increase the likelihood that there was non-coaxial alignment of the delivery system and sheath.The kinked loader also suggests the loader and delivery system was inserted at an angle into the sheath and that the loader may not have been fully inserted.Other procedural factors such as improper flushing/wetting of the devices and incomplete or misaligned valve crimping can also result in difficulty advancing the delivery system through the sheath.Available information supports that patient and/or procedural factors may have contributed to the reported event.According to the instructions for use (ifu), cardiovascular complications, including perforation or dissection of vessels which may require intervention, are potential adverse events associated with the transfemoral transcatheter aortic valve replacement procedure.In this case, as reported, the perforation of the right iliac artery was likely caused by the devices during removal.In addition, significant calcification and/or tortuosity, not always appreciable on imaging, could be contributing factors to the event.During manufacturing, the shaft was 100% inspected by manufacturing and quality for the following: the shaft od was dimensionally inspected, the tip id was dimensionally inspected, and the proximal flare was dimensionally inspected.The sheath shaft was visually inspected for: wrinkles, kinks, bends or mechanical damage, circumferentially oriented surface defects, protruding or missing material, dents, and cuts, cross linking of hdpe (blue) across liner (clear), delamination, and seam separation.The sheath shaft components were 100% visually inspected under minimum 3x magnification for the following: wrinkles, kinks, bends, or mechanical damage (including scratched/torn liner), circumferential oriented surface defects, protruding/missing material, dents, cuts, cross linking of hdpe (blue) across liner (clear), holes or tears on the strain relief, delamination, witness lines with exposed ptfe liner, remnant lines (white lines), seam separation, stress line(s) in the liner, notches on the bottom side of the liner when holding the housing in the left hand, flash and excess material, serrated transition, holes, or rough surface of tears in the tip.The esheath final assemblies were 100% visually inspected for the following: verify shaft od, distal tip id, working length, coating, and strain relief length, delamination, seam separation, wrinkles, kinks, bends, or mechanical damage (including scratched/torn liner), circumferential oriented surface defects, protruding/missing material, dents, cuts, witness lines with exposed ptfe liner, stress line(s) in the liner, cross linking of hdpe (blue) across liner (clear), notches on the bottom side of the liner when holding the housing in the left hand, remnant lines (white lines), holes or tears on the strain relief, serrated transition, holes, or rough surface on the tip interface, visually inspect the tip for flash and excess material, as well as for the presence of proper scoring on the od and id.Furthermore, after sterilization, product verification (pv) testing was performed.The verification includes expander insertion force testing.The lot passed this test.The inspections and tests described above support that it is unlikely a manufacturing non-conformance contributed to the reported complaint.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 confirmed based on visual inspection of the returned devices.No manufacturing non-conformances were identified.Based on a review of the device history record (dhr), lot history, and complaint history, there was no indication that a manufacturing non-conformance contributed to the reported event.A review of manufacturing mitigations supports that the esheath shaft has proper inspections in place to detect issues related to the reported event.Available information suggests that patient/procedural factors may have contributed to the reported event.No labeling or ifu inadequacies have been identified.As such, no corrective or preventative action is required at this time.

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: 7480506
• MDR Text Key: 107507863
• Report Number: 2015691-2018-01628
• 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
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2020
• Device Model Number: 9610ES16
• Device Lot Number: 61231478
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 05/17/2018; 07/10/2018; 07/23/2020
• Supplement Dates FDA Received: 06/12/2018; 07/13/2018; 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention