MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. ACIST; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	CVI
Health Effect - Clinical Codes	Aortic Dissection (2491); Vascular Dissection (3160)
Date of Event	04/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The acist angiographic injection system, model cvi, serial number (b)(4), was returned to acist on may 2, 2019.Upon completion of the investigation, a follow-up report will be submitted to fda.
Event or Problem Description
During a percutaneous coronary intervention (pci) to the right coronary artery (rca), the patient's rca and aorta were dissected.The patient was taken to emergency surgery and a saphenous vein graft to the rca was completed and the aorta was repaired.
Additional Manufacturer Narrative
The acist angiographic injection system, model cvi, serial number (b)(4) was returned to acist on may 2, 2019.The injector system was functionally tested and met the pre-established specifications.Acist's medical advisory board reviewed a copy of the cine-angiograms and information received from the user facility from the event: the films show a coronary angiogram of the left coronary system that is unremarkable.Subsequently, an angiogram of the right coronary artery (rca) demonstrates a significant stenosis in the distal rca.This is treated with balloon angioplasty and a stent is placed.On the last angio, dye injection is recorded and shows stent positioning and again is unremarkable.Subsequently, the stent is deployed and "post dilated".After the post dilation, the next image shows dye trapped in the mid and distal vessel consistent with dissection and what appears to be a large dissection into the wall of the aorta.The user facility reported that the dissection occurred with dye injection after post dilation; this injection image was not available in the cine-angiograms provided to acist.The instructions for use have been reviewed and no inadequacies were identified regarding warnings, contraindications, and the directions/conditions for the use of the device.There is no evidence of device malfunction related to this event and no inadequacies related to the device labeling/instructions for use.The cause of the event is unknown.This report is considered close.

• Brand Name: ACIST
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 8634899
• Report Number: 2134243-2019-00011
• Device Sequence Number: 1748358
• Product Code: DXT
• UDI-Device Identifier: 40841716101418
• UDI-Public: (01)40841716101418(11)180117
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K010390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2019

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 Model Number: CVI
• Device Catalogue Number: 014657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 07/14/2019
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR