MAUDE Adverse Event Report: MEDTRONIC, INC ADVANCE; CATHETER, EMBOLECTOMY

Model Number UNK-CV-DAN-EXP-ADV

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/14/2020

Event Type  Death  

Manufacturer Narrative

Journal article: inter-coronary thrombus migration in st elevation myocardial infarction (stemi) following power aspiration thrombectomy.Journal: tct 2020 year: 2020 ref: https://www.Tctmd.Com/slide/tct-677,date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A study titled- inter-coronary thrombus migration in st elevation myocardial infarction (stemi) following power aspiration thrombectomy, detailed a single case where a patient presented to the emergency room with persistent heartburn for 48hours.An angiogram showed an acute complete occlusion of the lad and timi grade 5 thrombus in the proximal lad extending to the ostium of the lad.A 6f judkins left 3.5 guide catheter was used to engage the left main artery and the patient was started on medication.The lad lesion was wired with a non-medtronic guidewire and predilated with 2.0 x 12mm semi--compliant balloon.Restoration of flow was not achieved.Timi 0 flow was noticed in distal lad.Bailout mechanical power aspiration was performed with a 5.3fr non-medtronic thrombectomy catheter.Partial successful thrombus aspiration was achieved.The thrombectomy catheter was removed and subsequent angiography revealed acute occlusion of the distal lcx with persistent ¿no reflow¿ in the lad.It was indicated that there was thrombus migration from the proximal lad into the distal lcx, which worsened the ischemic burden in an already severely compromised myocardium.As the thrombus burden was high, one possibility was that part of the lad thrombus was dislodged during withdrawal of the 5.3fr non-medtronic thrombectomy catheter into the guide and migrated into the distal lcx.Another possibility is that segments of fragmented thrombus could have dislodged into the distal lcx following contrast injection after thrombectomy especially when considering the factors including short left main, extension of thrombus to the ostial lad, and preferential increased flow in the lcx.An intra-aortic balloon pump (iabp) was placed to reduce myocardial work and possibly augment coronary flow.The lad was predilated again with a 2.0 x 15 non-compliant balloon and a 3.0 x 18 mm non-medtronic stent was placed which failed to improve distal flow.The lcx was wired with another non-medtronic guidewire and crossed the distal lesion.Aspiration thrombectomy of the distal lcx was performed using a 6f export aspiration catheter, however flow was not restored.The distal lcx was dilated with 1.5 x 20 mm non-compliant balloon.No-reflow persisted in the lad and lcx despite aspiration thrombectomy, balloon dilation, high doses of intracoronary adenosine and nicardipine and systemic gpiib/iiia inhibitor.The patient was transferred to cardiac icu.Echocardiography showed lvef to be 15% with severe anterior and inferolateral wall hypokinesis.The patient was transferred to a quaternary centre with hopes of undergoing emergent lvad with placement or heart transplantation.However, the patient went into multi-organ failure and passed away.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADVANCE
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 12244064
• MDR Text Key: 264028840
• Report Number: 1220452-2021-00030
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K152335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

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
• Device Operator: Health Professional
• Device Model Number: UNK-CV-DAN-EXP-ADV
• Device Catalogue Number: UNK-CV-DAN-EXP-ADV
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 10/08/2021
• Supplement Dates FDA Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 49 YR