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

Model Number UNK-CV-DAN-EXP-AP

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

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Shock (2072); Heart Failure (2206)

Event Date 02/21/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The aim of the article "long-term impact of thrombus aspiration in patients with st-elevation myocardial infarction undergoing primary percutaneous coronary intervention" was to investigate the 5-year clinical benefits of adjunctive thrombus aspiration (ta) during ppci compared with pci alone in stemi patients.A total of 563 patients who underwent ppci and had complete follow-up data were included.All stemi patients included in the total trial were referred for ppci within the 12 hours after symptom onset between january 2011 and november 2012 were retrospectively analyzed.For thrombectomy procedure, ta was to be the first procedure after the lesion was crossed with a guidewire, and the ta device, an export ap catheter, would be advanced, and aspiration started before it crossed lesion.A minimum of 2 syringes (40 ml) of aspirate during ta was recommended.The pci alone procedure was performed after aspiration was completed.For pci alone procedure, the operation was performed according to the operator¿s usual technique without the use of ta.The median follow-up for clinical outcomes was 5 years.Clinical outcomes reported included a composite of all-cause death, cardiovascular death, recurrent mi, cardiogenic shock, heart failure hospitalization, and stroke ta was significantly associated with a nearly sevenfold increased risk of stroke at 5 years compared with pci alone.The incidence rate of other major adverse cardiac events at 5 years in the ta group was similar to that in the pci group.The analysis demonstrated that all stroke events occurring within 12 months had presented at least 1 month later after the procedure.It is noted in the article that given the fact that ta derived stroke usually presents within 48 hours, which may be due to embolization of thrombus from the coronary vasculature or dislodgement of atheroma from the aorta to systemic vasculature, it is considered that the long-term stroke risk in the ta group was unlikely to be procedural origins.

• 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 ; IE ; 091708734
• MDR Report Key: 10282072
• MDR Text Key: 199042907
• Report Number: 1220452-2020-00060
• 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: 07/16/2020

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-AP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/16/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR