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 Death (1802); Hemorrhage/Bleeding (1888); Vascular Dissection (3160)

Event Date 03/12/2019

Event Type  Death  

Manufacturer Narrative

As of 8th april 2019, when the complaint analysis was completed, the following additional information was received: the break was seen at the level of the right common iliac.The cpr did not cause the break.The break refers to lotus introducer.Iliac rupture caused the pressure drop.The official cause of death was haemorrhage on the common right iliac.The patient condition before de procedure: (b)(6), sever aortic stenosis.The physician name: (b)(6).There were no other issues with implanting the acurate valve or advancing/ positioning the valve.The acurate device did not contributed to the patient death.Lotus introducer contributed to the patient death.Perforation occurred.It is believed that lotus introducer contributed to perforation.The cpr manoeuvres were continued for half an hour, but the pressure could not be restored, and the patient died.Product was not returned for review at the time of this report being completed.The device is not available for investigation and examination.It was therefore not possible to carry out any dimensional, functional, visual or microscopic examination on the device.Therefore, the primary reported classification lotus - patient - death and secondary reported classification lotus - patient - haemorrhage (intraperitoneal haemorrhage) cannot be determined.Following the investigation conclusions, the complaint analysed classification is assigned as lotus - product not returned - complaint unable to confirm.Clinical review: a video was received of the iliac rupture and sent to creganna medical advisor bonnie h.Weiner md msec mba senior medical director at boston medical for further review.Once the feedback is received the report will be reviewed and updated accordingly.Based on a review of the risk documentation and information available, no updates are required to the risk documentation for the lotus device.There is no indication of a potential processing or design failure associated with this complaint.There were no capa, (corrective and preventative action), mrr (material review report) or deviation generated for this lot, # 512190 during the manufacturing process that may have contributed to the reported issue.As of 8th april 2019, when the review was completed, there was no other complaint associated with lot number 512190 , for the as reported failures assigned as primary reported classification lotus - patient - death and secondary reported classification lotus - patient - haemorrhage (intraperitoneal haemorrhage).From the information available, there is no evidence present to indicate that the device was not used per the directions for use/product label.Haemorrhage and vessel dissection are anticipated procedural complications and are known physiological effect of the procedure as noted within the instructions for use (p/n 139816-01).Patient death is not included in ifu as anticipated procedural complication, therefore ifu will be updated.The complaint has been assigned as primary reported classification lotus - patient - death and secondary reported classification lotus - patient - haemorrhage (intraperitoneal haemorrhage).Following completion of creganna medical information review, the complaint analysed classification has been assigned as:" lotus - product not returned - complaint unable to confirm".Based on the complaint review and the event description, the complaint assigned as the primary reported classification lotus - patient - death and secondary reported classification lotus - patient - haemorrhage (intraperitoneal haemorrhage) could not be confirmed.The device was not returned for the investigation.Therefore, it was impossible to conduct visual and microscopic examination, dimensional and functional check or external evaluation.The complaint analysed classification has been assigned as (lotus - product not returned - complaint unable to confirm).There is no evidence of a potential processing or design failure associated with this complaint, no updates are required to the risk documentation for the lotus device.The complaint is reportable and has been escalated to the quality management team at this time.Based on the complaint review and the event description for this complaint, the root cause classification assigned to this complaint is 'adverse event related to patient condition.' '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.' as per the additional information received the patient had severe aortic stenosis.There is no evidence of a potential processing, design or use failure associated with this complaint.Based on the above conclusion, no further escalation or corrective action is required at this time.

Event Description

Complaint description received at creganna medical is as follows: initial complaint description received at creganna medical is as follows: "in a femoral limit with a minimum diameter of 5.8 without calcium lotus-s is used since the distributor had not sent isleeve.Resistance to the level of the common iliac is noted and, as it cannot progress, the procedure is continued with edwards e-sheath.The valve is successfully placed and, after the introducer is removed, a pressure drop occurs.Cpr, eco and angiography maneuvers are performed.It seems that a break is seen at the level of the right common iliac.The cpr maneuvers are continued for half an hour but pressure can not be restored and the patient dies.Where did the problem occur? inside the patient it was an implant of acurate s lot no.Spa332354, the valve was well placed.".

Manufacturer Narrative

When the iniial complaint analysis was completed, the following additional information was received; the break was seen at the level of the right common iliac.The cpr did not cause the break.The break refers to lotus introducer.Iliac rupture caused the pressure drop.The official cause of death was haemorrhage on the common right iliac.The patient condition before de procedure: 88 year old, sever aortic stenosis.The physician name: elena sanchez.There were no other issues with implanting the acurate valve or advancing/ positioning the valve.The acurate device did not contributed to the patient death.Lotus introducer contributed to the patient death.Perforation occurred.It is believed that lotus introducer contributed to perforation.The cpr manoeuvres were continued for half an hour, but the pressure could not be restored, and the patient died.This follow up report is being filed to include details of creganna's clinical input following review of the additional information.The clinical reviewer concluded that although the additonal information attributes the adverse event to the lotus sheath, the data is not definitive.The clinical stated that the lotus sheath could have contributed to the event, just as the other devices that were were subsequently placed.The fact that the bleeding wasn't clinically apparent until the sheath removal suggests that it could have been "tamponading" the initial perforation, but that again could have also been contributed by the subsequent devices.As they don't have an angiogram after the attempt with the lotus sheath, it makes it impossible to know the exact timing.The ultimate vessel rupture would likely not have been contained throughout the procedure and therefore could have occurred with any of the device removals as well.The compliant device was not returned to creganna medical for review at the time this report was completed.Should the device be returned at a later date, a follow up report will be filed with the fda.As the complaint device was not returned to creganna medical, it was therefore not possible to carry out any dimensional, functional, visual or microscopic examination on the device.As such, the reported issue cannot be confirmed.A review of the manufacturing documentation was completed.There were no capas (corrective and preventative action), mrrs (material review report) or deviations generated for this lot, #512190 during the manufacturing process that may have contributed to the reported issue.As of (b)(6) 2019 when the complaint analysis review was completed, there was no other complaint associated with lot number #ot, # 512190, for the reported failure mode (patient death and patient - haemorrhage /intraperitoneal haemorrhage).A review of risk management documentation was completed.Based on this review and information available, it was concluded that there is no indication of a potential processing or design failure associated with this complaint and therefore no updates are required to the risk documentation due to the reported incident.From the information available, there is no evidence present to indicate that the device was not used per the directions for use/product label.Haemorrhage and vessel dissection are anticipated procedural complications and are known physiological effect of the procedure as noted within the instructions for use.Patient death is not included in the ifu as an anticipated procedural complication, therefore ifu will be updated to add this adverse event.Based on the complaint review and the event description for this complaint, the root cause classification assigned to this complaint is adverse event related to patient condition' which is described as '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.' as per the additional information received the patient had severe aortic stenosis.This complaint was escalated to the quality management team.Based on the above conclusion no further escalation or corrective action is required at this time.We will continue to monitor for these complaint types.

Event Description

Complaint description received at creganna medical is as follows: 'initial complaint description received at creganna medical is as follows: "in a femoral limit with a minimum diameter of 5.8 without calcium lotus-s is used since the distributor had not sent isleeve.Resistance to the level of the common iliac is noted and, as it cannot progress, the procedure is continued with edwards e-sheath.The valve is successfully placed and, after the introducer is removed, a pressure drop occurs.Cpr, eco and angiography maneuvers are performed.It seems that a break is seen at the level of the right common iliac.The cpr maneuvers are continued for half an hour but pressure can not be restored and the patient dies.Where did the problem occur? inside the patient it was an implant of acurate s lot no.Spa332354, the valve was well placed.".

• 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
• MDR Report Key: 8508864
• MDR Text Key: 141758384
• Report Number: 3004193842-2019-00004
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05391526210109
• UDI-Public: (01)05391526210109(17)200818(10)512190
• Combination Product (y/n): N
• PMA/PMN Number: K140338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2020
• Device Model Number: H749NTR180
• Device Catalogue Number: LIS-S
• Device Lot Number: 512190
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 88 YR