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

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

Patient Problems Myocardial Infarction (1969); Thrombosis/Thrombus (4440)

Event Date 07/27/2020

Event Type  Death  

Manufacturer Narrative

Journal article: covid-19 infection and high intracoronary thrombus burden, year: 2020, ref: doi: 10.1016/j.Carrev.2020.07.032.Date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

An article titled; covid-19 infection and high intracoronary thrombus burden, was submitted for review.Due to evidence that there is a strong association between covid-19 and high intracoronary thrombus burden this article presents a case report to review the mechanism of the high thrombus burden.The article reports that a patient attended the emergency department with fever, dry cough and breathlessness for the last week.On examination the patient had widespread crepitations bilaterally.Chest radiograph demonstrated widespread bilateral consolidation with patchy peripheral ground glass changes, highly suggestive of covid-19.Initial electrocardiogram (ekg) was reported as showing no ischemic changes.The patient's condition rapidly deteriorated and oxygen saturation diminished.The patient was therefore commenced on continuous positive airway pressure.An hour later the patient became more fatigued with increased respiratory effort and was intubated and ventilated.Four minutes later the patient sustained a cardiac arrest with pulseless electrical activity (pea).4 cycles of cardiopulmonary resuscitation (cpr) were performed with intravenous adrenaline, cardiac output was re-established, and a subsequent ekg demonstrated inferior stemi.The patient was transferred to the cardiac catheterization laboratory for emergency coronary angioplasty.Coronary angiogram showed mild atheroma in the left coronary system and a thrombotic occlusion of the proximal segment of a dominant right coronary artery (rca).A non- medtronic guidewire was advanced to the distal rca and an export advance aspiration catheter was subsequently used.A high burden of mixed red and white thrombi was aspirated, however thrombolysis in myocardial infarction (timi) flow remained 0.Intracoronary glycoprotein was delivered via the aspiration catheter.Serial balloon inflations with semi-compliant balloons improved flow to timi i up to the mid-vessel with evidence of significant residual thrombus.Multiple further aspirations were performed albeit with no change in flow.Intracoronary thrombolytic agent was then administered through a non medtronic microcatheter with again no improvement in timi flow.The patient developed complete heart block therefore a temporary pacing wire was inserted.It was decided to stop the procedure.The patient became more hypoxic and sustained a second pea arrest.A transthoracic echocardiogram showed no evidence of pericardial effusion.Several cycles of cpr were attempted to no avail.Due to the rapid nature of the patient's deterioration and respiratory arrest, extracorporeal membrane oxygenation (ecmo) was not considered and unfortunately the patient passed away.Subsequently, it was confirmed that the patient's nasopharyngeal swab was positive for severe acute respiratory syndrome coronavirus 2.

• Brand Name: ADVANCE
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13001257
• MDR Text Key: 282206625
• Report Number: 1220452-2021-00083
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K152335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Race: White