MAUDE Adverse Event Report: MEDTRONIC, INC EXPORT AP ASPIRATION CATHETER; CATHETER, EMBOLECTOMY

Device Problem Suction Problem (2170)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

Lit ref:doi.Org/10.1186/s12872-018-0951-9.If information is provided in the future, a supplemental report will be issued.

Event Description

A heavy smoker with no specific medical history was admitted to hospital with severe chest pain lasting 2 h.Blood pressure was 130/80 mmhg on admission, and the patient presented with no laterality in the upper extremities.Electrocardiography on arrival showed st-segment elevation in leads ii, iii, and avf.The patient was diagnosed with inferior st-segment elevation myocardial infarction (stemi) in killip class i and immediately brought to the cardiac catheterization laboratory.An emergency coronary angiography revealed a large filling defect extending from the distal lm artery into the proximal lcx artery.Otherwise, no significant lesions were found and thrombolysis in myocardial infarction (timi) iii flows were observed in all coronary arteries.Therefore, pci was performed using a 6fr medtronic guiding catheter.Unfortunately, while a non-medtronic 0.014-in.Guidewire crossed the lm artery, the whole thrombus was extracted from the proximal lcx artery and pushed into the lad artery.The proximal lad artery was completely occluded by the thrombus.After crossing the lesion in the lad artery with the non-medtronic guidewire, thrombectomy was attempted several times using an export aspiration catheter, and the intracoronary administration of glycoprotein iibiiia inhibitor was slowly infused.However, these treatments did not reduce the thrombus burden in the proximal lad artery, and no visible thrombus was detected in the aspirate.Then, a 14-atm dilation of a non-medtronic semicompliant balloon was performed in the lesion.However, the thrombus moved to the middle lad artery with timi flow 0.Following the failure of another attempt of aspiration using an export catheter (medtronic), thrombus extraction from the lad artery was considered as impossible.Further procedures were performed and the patient was transferred to the coronary intensive care unit in a hemodynamically stable condition, while the st elevation subsided.The patient was started on low-molecular-weight heparin in addition to regular aspirin, ticagrelor and rosuvastatin.Glycoprotein iibiiia inhibitor administration was continued for 24 h.The immunological screen results were unremarkable.A follow-up coronary angiography was performed 1 week later, which revealed the restoration of timi 3 flow and the complete resolution of thrombus in the left coronary artery.Intravascular ultrasound (ivus) showed nonsignificant residual stenosis of the lm artery.Echocardiography revealed the left ventricular ejection fraction (ef) was 61% with a slight apex hypokinesis, the patient had an uncomplicated recovery and was discharged after 2 days.No adverse events occurred during a 12-month follow-up period.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXPORT AP ASPIRATION CATHETER
• 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 ; 091708734
• MDR Report Key: 8280584
• MDR Text Key: 134177974
• Report Number: 1220452-2019-00010
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 01/28/2019
• Supplement Dates Manufacturer Received: 04/16/2019
• Supplement Dates FDA Received: 04/16/2019
• 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): Required Intervention
• Patient Age: 41 YR