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

Model Number	H749NTR200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Vascular Dissection (3160)
Date of Event	05/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 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.The physician confirmed that the primary classification as lotus - patient - vessel dissection cannot be determined as the device was not available for review following the investigation conclusion, the compliant analysed classification is assigned as lotus - product not returned - complaint unable to confirm.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 been escalated to the quality management team.A review of the manufacturing documentation for lot# 521463 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.As of 08th july 2019, when the review was completed, there was no other complaint associated with lot number 521463, for the as reported primary classification as lotus - patient - vessel dissection.From the information available, there is no evidence present to indicate that the device was not used per the directions for use/product label.Following the investigation conclusion, the compliant analysed classification is assigned as lotus - product not returned - complaint unable to confirm.Following a review of the risk documentation and information available, no updates are required to the risk documentation for the lotus introducer set device.There is no indication of a potential processing or design failure associated with this complaint.The compliant is reportable.Upon above information, the complaint has been escalated to the quality management team.The probable investigation conclusion code assigned to this complaint is 'known inherent risk of device.The definition of known inherent risk of device is: 'reported adverse event known and documented in the labelling (including both short or long term known complications or adverse reactions)'.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 or Problem Description
Complaint description received at creganna medical is as follows: event description: per ctsenr, it was reported that: reprise iv (b)(4) (acute retroperitoneal bleed from right common femoral artery, 1st degree a-v block) event description: 1st degree a-v block (002- ae)/ left groin hematoma (001- major vascular complication)/ acute retroperitoneal bleed from right common femoral artery (003- repeat procedure for valve-related dysfunction): on (b)(6) 2019, same day of the index procedure, subject developed 1st degree av block (002), left groin hematoma and acute retroperitoneal bleed.No additional diagnostics or actions were taken with regards to ae 002.Per edc, ultrasound and angiogram were performed and the subject was diagnosed with major vascular complication (001).Type of vascular complication: percutaneous closure device failure (site has been queried to confirm the type of vascular complication) -the event# 001 was medically treated and angioplasty to left sfa under ultrasound guidance was performed.Per edc, ct scan, lab tests and ultrasound were performed as diagnostics for event # 003 and the event led to prolongation of index hospitalization and was medically treated.Per (b)(6) 2019 ctsern received: procedure summary: the subject was enrolled into the reprise iv on (b)(6) 2019.Prior to the index procedure, heparin or other anticoagulant was given.On (b)(6) 2019, the subject received loading dose of 324 mg of aspirin and 300 mg of clopidogrel.A lotus introducer was placed and then the aortic valve was treated with deployment of a 23 mm lotus edge? valve system.Balloon valvuloplasty was not performed.Successful repositioning of the lotus edge valve involved partial resheathing of the lotus edge valve in the delivery system catheter and deployment into a more accurate position within the aortic annulus.Retrieval was not attempted.On (b)(6) 2019, same day of the index procedure, subject developed 1st degree av block (002), left groin hematoma and acute retroperitoneal bleed.No additional diagnostics or actions were taken with regards to ae 002.Per edc, ultrasound and angiogram were performed and the subject was diagnosed with major vascular complication (001).-type of vascular complication: percutaneous closure device failure (site has been queried to confirm the type of vascular complication) -the event# 001 was medically treated and angioplasty to left sfa under ultrasound guidance was performed.Per edc, ct scan, lab tests and ultrasound were performed as diagnostics for event # 003 and the event led to prolongation of index hospitalization and was medically treated.On (b)(6) 2019, hematological measurements revealed (please see lab table below for additional values): lowest hemoglobin level associated with the event: 7.0 g/dl (standard reference range: 12.0-15.5 g/dl).Lowest hematocrit value associated with event: 20.1 % (standard reference range: 37-48%).-no blood transfusion was performed.Per edc varc classification for bleeding event was major.At the time of reporting the event (ae# 002 and 003) were considered to be not recovered/not resolved.At the time of reporting the event (ae# 001) was considered to be recovering/ resolving.Potential relationship to study device per investigator (001, 002, 003): causal relationship lab data: test date test name norm low-high results units (b)(6) 2019 hematocrit - 37.1 % (v/v) (b)(6) 2019 hematocrit - 20.1 % (v/v) (b)(6) 2019 hemoglobin - 12.1 g/dl (b)(6) 2019 hemoglobin - 7.0 g/dl as per crf updates received, site has updated the ?relationship to study device? for ae 003 ? acute retroperitoneal bleed from right common femoral artery? from ? causal relationship? to ? not related?.Hence an downgraded complaint is being processed for the same.Complaint was entered due to additional information received 03 june 2019 - cause of the event "could be closure device or the introducer." lot: 0000521463, record id: (b)(4), as reported classification vessel dissection.

• Brand Name: LOTUS INTRODUCER SET
• Common Device Name: 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: 8797074
• Report Number: 3004193842-2019-00008
• Device Sequence Number: 11564715
• Product Code: DYB
• UDI-Device Identifier: 05391526210116
• UDI-Public: (01)05391526210116(17)201111(10)521463
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2020
• Device Model Number: H749NTR200
• Device Catalogue Number: LIS-L
• Device Lot Number: 521463
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention