MAUDE Adverse Event Report: CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL LOTUS INTRODUCER SET; INTRODUCER CATHETER

Model Number H749NTR200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Perforation of Vessels (2135)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

The complaint product was returned to creganna medical for analysis.The observations made during the analysis found the following: the lotus introducer sheath was returned with the lotus edge delivery system inside.The dilator was not returned together with the sheath.There was evidence of blood on the device.The lotus edge delivery system could not be removed from the lotus introducer sheath there was bunching observed between 20-30mm from the distal tip.There was some further bunching observed along the length of the catheter at 200 mm extending 70mm proximally.There was damage noted on the distal tip.There was no damage on the homeostasis hub valve.Examination of the returned devices was carried out in bsc galway.There was no evidence of any issues with the lotus introducer sheath.There was some flattening (pancaking) observed on the lotus edge delivery system shaft.The lotus introducer system was removed from the lotus edge delivery by cutting the lotus introducer system longitudinally to remove it.Based on the investigation conducted the complaint, the reported issue could be confirmed.The analysis conducted confirms the lotus edge valve implant could not be resheated or removed through the lotus introducer system.The complaint investigation confirmed the lotus edge delivery system was stuck inside the lotus introducer system.Following the investigation results the complaint primary analysed classification is assigned as introducer sheath - device stuck inside and introducer sheath - broken/damaged.A review of the case was completed by creganna medical clinician and the findings are detailed as follows: "this sounds like an unfortunate case but the primary issue appears to be with the valve, not the lotus sheath.If they were never able to resheath the valve in the delivery device because the delivery system was malfunctioning or over torqued or some combination of those factors, which sounds like was the case, then what they pulled back through the iliac artery was larger and more traumatic than what would have been the profile of the sheath itself or a resheathed valve system.That is the most likely etiology of the trauma that resulted in the perforation.It also sounds like it likely occurred before they deployed the corevalve which again would be consistent with it having been related to the removal of the entire system as a unit where the partially deployed valve was likely the cause of the injury.As with most of these cases, it would be good to know the size of the iliac artery since they also describe the anatomy as calcified and tortuous but i don't think it would change my opinion of what happened".An additional review was completed by creganna medical clinician on 03-jan-2020 once the additional information was received and the findings are detailed as follows: 'the description of events does not change my opinion on this case.The imaging certainly confirms the description that the vessels were relatively small and heavily calcified.The right iliac system is relatively straight and the major tortuosity is actually in the aorta.During withdrawal of the valve and sheath as a unit the angulations may have played a role in the perforation.As i previously commented, it is more likely that the inability to resheath the valve and the profile of the entire system being withdrawn that was responsible for the complication, not the sheath itself.The patient anatomy was likely a contributing factor.' the clinical review is in line with the findings of the investigation, identifying the challenges associated with the patient anatomy and the potential for damage during insertion and withdrawal of the devices.A review of risk management documentation was completed.Based on a review of the risk documentation and information available, no updates are required to the risk documentation for the lotus introducer sheath device.There is no indication of a potential processing or design failure associated with this complaint.This complaint has not been escalated to the quality management team.A review of the manufacturing documentation was completed.The manufacturing documentation for lot# 00000011151 and all its subcomponents was completed and found that the device met its material, assembly and product specifications at the time of release to distribution.The review of the router and subsequent sub assembly routers did not highlight any anomalies.As of 22-jan-2020, when the review was completed, there was no other complaint associated with lot number 00000011151 for the reported issue.From the information available, there is no evidence present to indicate that the lotus introducer sheath was not used per the directions for use/product label.Following the investigation results the most probable root cause investigation conclusion code assigned to this complaint is [']adverse event related to patient condition'.The definition of adverse event related to patient condition is: 'an existing condition or disease is demonstrably responsible for the adverse event and use of the device has neither caused nor otherwise influenced this condition/disease-related adverse event.The patient's anatomy is described as calcified and extremely tortuous with the calibre of the vessels described as small.Considerable torque was required to deliver device through anatomy.Information received on this case also detailed it is hard to determine exactly what bsc devices contributed to the perforation and it could potentially be either initial lis on insertion or removal of lotus (edge delivery system).It was also observed through the case information that the lotus edge valve implant was not successfully implanted, and it was not possible to fully resheath the lotus edge valve implant as such the lotus edge valve implant was unable to be fully constrained and wouldn't fit through sheath.Review of the complaint information indicates the that the existing condition or disease is demonstrably responsible for the adverse event and may have been responsible for the performance of the lotus edge delivery system and the vascular injury.This complaint has been escalated to the quality management team.Based on the above conclusion, no further escalation or corrective action is required at this time.Creganna medical will continue to monitor for these complaint types.

Event Description

Complaint description received at creganna medical is as follows: event description: per update received on cnf, it was reported that: unable to lock valve and then unable to resheath valve fully.Removed partially flowered device and sheath at the same time.Iliac perforation and extravasation.Access route tf location right tf access percutaneous guidewire used safari2 (xs) other wire lundrquist sheath used lis other sheath embolic protection used none.Per email, it was reported that: summary: difficulty locking and resheathing device.Patient death.Valve was prepped without issue as per dfu.Patient anatomy was calcified and extremely tortuous.Standard tavr procedure.Lotus lis sheath in right common femoral artery.Contralateral access for lunderquist buddy wire to facilitate device tracking through tortuosity.Device was delivered to aortic annulus.Considerable torque was required to deliver through anatomy.Deployment of device: ? first result was high, asymmetric unsheathing? second deployment was attempted with lower starting point.Prior to locking, twisted post was identified, resheathing attempted to fix.? third deployment twisted post was again noticed.Physician called for a medtronic core valve to complete case.When resheathing of valve was attempted to remove the valve, the physician was only able to partially resheath the valve.Control knob was at the end of travel and it was noticed that there was ?according? of the outer catheter.The valve and the lis were removed as one with the valve partially flowered.A new lis was prepped and inserted.Patient was hemodynamically unstable from ai and a corevalve 29mm was implanted.Patient remained unstable and extravasation from the r iliac system was appreciated.Multiple viabahn covered stent grafts were deployed to manage iliac perforation.Complete seal of the perforation was not achieved and patient expired.Event date: (b)(6) 2019.As of 22-jan-2020, when the complaint analysis was completed, the following additional information was received; the physicians name and doctors address was provided.The following information was provided giving additional clarification on case details.What is meant by "control knob was at the end of travel" ? blue control knob would not rotate away from user any further.Why was the valve not able to be fully resheathed? for engineering to determine but i believe bc outer catheter according.What bsc devices contributed to the perforation? hard to determine exactly, either initial lis on insertion or removal of lotus when and how was the perforation observed - before insertion of the second lis? on removal of the first lis and lotus system is there any allegation against the 2nd lis? no official cause of death? don't know "official" cause.Would have to ask hospital how they report.Cardiac arrest due to exsanguination would be my thought.Can anonymized event-related media please be provided for analysis? have asked hospital.No response as of yet how did the patient's anatomy contribute to the difficulties delivering the valve? see 3mensio: tortuosity, calcium, caliber of vessel what specific post was twisted? with marker to left of screen, the center post.Was bav performed? yes, 20mm in the physician's opinion, what caused the twisted post to occur? physician doesn't have an opinion on twisted post.Why was the leds and lis removed together? because the lotus was unable to be fully constrained and wouldn't fit through sheath.At what point in the procedure was the dissection noted? during use of lotus edge, after removal of lotus edge, during implant of corevalve, post corevalve implantation? after corevalve was implanted.When they were resheathing, did they see anything that would prevent the valve from being resheathed? os damage- severe torque applied to the system by the physician was the haemodynamic instability the result of the dissection or the original indication? seen ai implanted corevalve.Seen extravasation on the way out.Stabilised patient with viabahn stents.Stents separated.

• Brand Name: LOTUS INTRODUCER SET
• Type of Device: INTRODUCER CATHETER
• Manufacturer (Section D): CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL; parkmore west; galway, H91 V N2T; EI H91 VN2T
• Manufacturer (Section G): CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL; parkmore west; galway, H91 V N2T; EI H91 VN2T
• Manufacturer Contact: olivia odhiambo ; parkmore west; galway, H91 V-N2T ; EI H91 VN2T
• MDR Report Key: 9622424
• MDR Text Key: 190067440
• Report Number: 3004193842-2020-00001
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05391526210116
• UDI-Public: (01)05391526210116(17)210709(10)00000011151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2021
• Device Model Number: H749NTR200
• Device Catalogue Number: LIS-L
• Device Lot Number: 00000011151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention