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

Model Number H749NTR180

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Vascular System (Circulation), Impaired (2572)

Event Date 03/31/2015

Event Type  Injury  

Event Description

Event(s) description 1: per (b)(4) worksheet: lfa access for lotus introducer - small.Difficult access due to diseased/calcified aortoiliac bifurcation.Introducer tip inserted just distal to bifurcation.The lotus introducer was removed and an angio was performed to access descending aorta, iliacs and femorals.A lfa perforation was discovered.A pta balloon was inserted to attempt to seal the perforation.Balloon inflations were unsuccessful in sealing the perforation.Dr.(b)(6) performed a cutdown procedure and successfully fixed the perforation.Per crf: occlusion of the left femoral artery with acute bleeding.The subject underwent left femoral endarterectomy and bovine patch and required 2 units of prbcs.Lowest hematocrit value associated with the ae is 25% on (b)(6) 2015 and the lowest hemoglobin value associated with the event is 8.5 g/dl on (b)(6) 2015.The event the event was recovered/resolved on (b)(6) 2015.The event was related to study procedure and unrelated to the study device.

Manufacturer Narrative

This follow-up mdr is to give an update on the investigation findings by creganna medical in relation to this event as follows: (b)(6) clinical trial is a randomized, controlled study to evaluate the safety and effectiveness of the lotus¿ valve system in patients with calcific, severe aortic stenosis and who are considered to be at either high or extreme risk for surgical valve replacement.A review of the manufacturing documentation for lot# 253853 and all of 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.A similar complaint review was completed for lot 253853.This review concluded that three further complaints (lot-pc15-028, lot-pc15-033 lot-pc17-014) were opened specific to lot 253853 where a similar as reported event was reported however vessel dissection is an anticipated procedural complication and is due to a known physiological effect of the procedure as noted within the instructions for use.Vessel dissection is a common 'as reported' classification.All complaints mentioned above relate to product used in reprise clinical trials which assesses patients with calcific, severe aortic stenosis therefore there is no requirement for any further action in relation to this trend.A ship history review was completed and found that (b)(4) units from the lot# 253853 were shipped to (b)(6) on 19-dec-2014.From the information available, there is no evidence present to indicate that the device was not used per the directions for use/product label.The device was not returned to the manufacturing site therefore a technical analysis could not be completed.Based on a review of the fmeas and based on this complaint investigation no updates are required to the risk documentation for the lotus introducer sheath at this time.There is no indication of a potential processing, design or use failure associated with this complaint.The device was not returned for review.Damage to the vessel is considered in multiple places within the risk documentation and is not a new or unanticipated failure mode.We will continue to monitor occurrence rates per the risk documentation.Based on the device review and the event description for this complaint, the root cause classification assigned to this complaint is 'anticipated procedural complication'.An 'anticipated procedural complication ' is defined as where 'the complaint is due to a known physiological effect of the procedure noted within the instructions for use, and or device labelling'.Based on the above conclusion there is no need to escalate this complaint any further.Not returned to manufacturer.

Event Description

Initial complaint description received is as follows: 'event(s) description 1:per fce worksheet: lfa access for lotus introducer - small.Difficult access due to diseased/calcified aortoiliac bifurcation.Introducer tip inserted just distal to bifurcation.The lotus introducer was removed and an angio was performed to access descending aorta, iliacs and femorals.A lfa perforation was discovered.A pta balloon was inserted to attempt to seal the perforation.Balloon inflations were unsuccessful in sealing the perforation.Dr.(b)(6) performed a cutdown procedure and successfully fixed the perforation.Per crf:ae001-occlusion of the left femoral artery with acute bleeding.The subject underwent left femoral endarterectomy and bovine patch and required 2 units of prbcs.Lowest hematocrit value associated with the ae is 25% on (b)(6) 2015 and the lowest hemoglobin value associated with the event is 8.5 g/dl on (b)(6) 2015.The event was recovered/resolved on (b)(6) 2015.The event was related to study procedure and unrelated to the study device.'.

Manufacturer Narrative

This follow-up mdr is to give an update (correction) on the investigation findings by creganna medical in relation to this event as follows: correction:mfr report # 3004193842-2017-00015 follow up 1 had indicated that lot 253853 was previously reported for vessel dissection.However as this mdr report is based on the adverse event being reported as vessel perforation with acute bleeding, information previously submitted regarding vessel dissection is irrelevant to the investigation report.Please find the updated investigation summary below: reprise clinical trial is a randomized, controlled study to evaluate the safety and effectiveness of the lotus¿ valve system in patients with calcific, severe aortic stenosis and who are considered to be at either high or extreme risk for surgical valve replacement.A review of the manufacturing documentation for lot# 253853 and all of 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.A similar complaint review was completed for lot 253853.This review concluded that no further complaints were opened specific to lot 253853 where a similar as reported event was reported however vessel perforation is an anticipated procedural complication and is due to a known physiological effect of the procedure as noted within the instructions for use.Vessel perforation is a common 'as reported' classification.All complaints mentioned above relate to product used in reprise clinical trials which assesses patients with calcific, severe aortic stenosis therefore there is no requirement for any further action in relation to this trend.A ship history review was completed and found that (b)(4) units from the lot# 253853 were shipped to (b)(4) european distribution centre, (b)(4) on 19-dec -2014.From the information available, there is no evidence present to indicate that the device was not used per the directions for use/product label.The device was not returned to the manufacturing site therefore a technical analysis could not be completed.Based on a review of the fmeas and based on this complaint investigation no updates are required to the risk documentation for the lotus introducer sheath at this time.There is no indication of a potential processing, design or use failure associated with this complaint.The device was not returned for review.Damage to the vessel is considered in multiple places within the risk documentation and is not a new or unanticipated failure mode.Creganna medical will continue to monitor occurrence rates per the risk documentation.Based on the device review and the event description for this complaint, the root cause classification assigned to this complaint is 'anticipated procedural complication'.'anticipated procedural complication ' is defined as where 'the complaint is due to a known physiological effect of the procedure noted within the instructions for use, and or device labelling'.Based on the above conclusion there is no need to escalate this complaint any further.Not returned to manufacturer.

Event Description

Initial complaint description received is as follows: 'event(s) description 1: per fce worksheet: lfa access for lotus introducer - small.Difficult access due to diseased/calcified aortoiliac bifurcation.Introducer tip inserted just distal to bifurcation.The lotus introducer was removed and an angio was performed to access descending aorta, iliacs and femorals.A lfa perforation was discovered.A pta balloon was inserted to attempt to seal the perforation.Balloon inflations were unsuccessful in sealing the perforation.Dr.(b)(6) performed a cutdown procedure and successfully fixed the perforation.Per crf:ae001-occlusion of the left femoral artery with acute bleeding.The subject underwent left femoral endarterectomy and bovine patch and required 2 units of prbcs.Lowest hematocrit value associated with the ae is 25% on (b)(6) 2015 and the lowest hemoglobin value associated with the event is 8.5 g/dl on (b)(6) 2015.The event was recovered/resolved on (b)(6) 2015.The event was related to study procedure and unrelated to the study device.'.

• 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: mako sugimura ; parkmore west; galway, H91 V-N2T ; EI H91 VN2T ; 5391757801
• MDR Report Key: 6394476
• MDR Text Key: 69559738
• Report Number: 3004193842-2017-00015
• Device Sequence Number: 1
• Product Code: DYB
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: H749NTR180
• Device Catalogue Number: LIS-S
• Device Lot Number: 253853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention