MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE SYSTEM; LOTUS EDGE TM VALVE SYSTEM 27 MM

Model Number 10394

Device Problems Failure to Advance (2524); Device-Device Incompatibility (2919); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the lotus edge valve delivery system was received for analysis.The valve was sheathed to the nosecone and the distal end of the outer sheath was kinked 25mm proximal from distal tip of nosecone.A visible transition in the outer sheath's hydrophilic coating was observed 185mm from the distal tip of nosecone.This transition would indicate how far the device travelled into the introducer.There was no other damage to the lotus edge device identified during the product analysis.

Event Description

It was reported that compression of a lotus edge valve delivery catheter occurred.The native aortic annulus was moderately to severely calcified in a circular pattern with calcification of the left ventricular outflow tract on the non coronary cusp and left coronary cusp side.The aortic arch was long.There was an elongated atheroma in the right femoral artery.A size large lotus introducer sheath (lot 546440) was inserted with the dilator into the patient's right femoral artery.A 27mm lotus edge valve system(lot 23630112) was introduced in accordance with the instructions for use.After advancing about 15cm the physician stated that the lotus edge valve delivery system could not be advanced any further into the lotus introducer sheath.The angiography showed a kink of the lotus introducer.The lotus edge valve system and lotus introducer sheath were removed.The lotus edge valve delivery system had a compressed appearance approximately 5cm from the nosecone on the outer catheter.No patient harm occurred.A new size large lotus introducer sheath (lot 546440) and a new 27mm lotus edge valve (lot 23587499) were prepared.The lotus introducer sheath was inserted into the patient's anatomy using the dilator.The 27mm lotus edge valve was introduced in accordance with the instructions for use.A kink of the lotus introducer sheath occurred.The lotus edge valve delivery system was able to pass the lotus introducer for advancement, however before the passage of the aortic arch, a kink of the lotus edge valve delivery system was identified.According to the instructions for use, the user was informed that a kinked lotus edge valve delivery system should not be used.As a result, the lotus introducer sheath and lotus edge valve were removed.No patient injury has occurred.A new size large lotus introducer sheath (lot 528310) and a new 27mm lotus edge valve (lot 23745137) were prepared.The lotus introducer sheath was inserted into the patient's right femoral artery using a dilator.The 27mm lotus edge valve was introduced in accordance with the instructions for use.After advancing approximately 20cm the lotus valve system could not be advanced further through the lotus introducer sheath.The lotus introducer sheath had kinked.The lotus introducer sheath was then removed.The physician decided to use a non boston scientific sheath.The lotus edge valve system was introduced through the new introducer sheath in accordance with the instructions for use.Before passage of the aortic arch a kink was visible on the lotus edge valve delivery system.According to the instructions for use, the user was informed that a kinked lotus edge valve delivery system should not be used.The physician decided to continue the procedure.There were multiple positioning attempts of the lotus edge valve, with multiple partial and three full resheaths.The physician was aware that the maximum of one full resheath is in accordance with the directions for use.The valve frame positioned in the left coronary cusp was lower than the valve frame in the non coronary cusp.The physician felt it was difficult to control the release of the valve.An unusual waist was seen on the lotus edge valve, similar to a barrel shape.The lotus edge valve position was mostly too low.The 3 cusp view was difficult to adjust.There were multiple attempts to optimize implant placement.The patient was given a high dose of pain medication which caused hypotension due to respiratory insufficiency.Circulatory support with catecholamines was administered for approximately 10 minutes.With increasing circulatory instability of the patient, it was decided to remove the lotus edge valve and implant a 26mm non boston scientific valve.Post dilation was done with a 24mm and a 26mm balloon.Post procedure, the patient was placed in the intensive care unit.Some days later was moved to the 'normal' cardiac unit.The patient was discharged from the hospital seven days post procedure.However, returned device analysis revealed a delivery system kink.

• Brand Name: LOTUS EDGE VALVE SYSTEM
• Type of Device: LOTUS EDGE TM VALVE SYSTEM 27 MM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9268077
• MDR Text Key: 166984346
• Report Number: 2134265-2019-12844
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2020
• Device Model Number: 10394
• Device Catalogue Number: 10394
• Device Lot Number: 0023630112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR