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

Device Problem Suction Problem (2170)

Patient Problem Injury (2348)

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

Patient was admitted to hospital with severe chest pain lasting 2 h.Blood pressure was 130/80 mmhg on admission, and presented with no laterality in the upper extremities.Electrocardiography on arrival showed st-segment elevation.Patient was diagnosed with inferior st-segment elevation myocardial in-farction(stemi) 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 6 fr guiding catheter(ebu3.5, medtronic).While a 0.014-in.Non-medtronic 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 aspiration catheter (export, medtronic).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 semi compliant 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.The initial angiogram showed no stenosis in the lad artery, which had diameters above 2.5 mm and above 1.5 mm at the distal and terminal sites, respectively.To reduce the infarct size, the thrombus was pushed to the terminal lad artery.A dilated non-medtronic balloon with 6 atm was used to push the thrombus carefully toward the distal lad artery.Furthermore, the contracted non-medtronic balloon was successfully pushed the thrombus to the terminal lad artery.The final angiogram demonstrated no other significant stenosis except the embolization in the terminal site of the lad artery; thus, stent deployment was not performed.The patient was transferred to the coronary intensive care unit in a hemodynamically stable condition, while st elevation subsided.Patient was started on medication.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.The patient had an uncomplicated recovery and was discharged after 2 days.No adverse events occurred during a 12-month follow-up period.

• 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: 8455137
• MDR Text Key: 139957078
• Report Number: 1220452-2019-00034
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120808
• 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
• Report Date: 03/27/2019

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: 03/11/2019
• Initial Date FDA Received: 03/27/2019
• 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