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

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

Patient Problems Unspecified Infection (1930); Rupture (2208); Thrombosis/Thrombus (4440)

Event Date 11/01/2021

Event Type  Injury  

Event Description

A journal article titled - atypical st-segment-elevation myocardial infarction presentation in patients with covid-19 at a high-volume center in new york city - was submitted for review.The aim of this journal article was to retrospectively study atypical presentations of st-segment-elevation myocardial infarction (stemi) in patients with covid-19.Of 43 patients who underwent coronary angiography when stemi was suspected, 33 had negative results for covid-19 and 10 had positive results.Patients diagnosed with both covid-19 and stemi were divided further into subgroups of those who had (six patients), or did not have (four patients), a culprit coronary lesion.Of the 33 patients without covid-19, 32 presented to hospital with chest pain, while two had a fever and one patient was intubated because of respiratory distress on admission.Focal st-segment elevation (ste) was present in 30 patients, and 26 patients had regional wall-motion abnormalities (rwma) on transthoracic echocardiograms (tte).Two patients had cardiogenic shock (cs) on presentation, and nine underwent intra-aortic balloon pump (iabp) placement.A culprit lesion was identified in 32 patients, allof whom underwent percutaneous coronary intervention (pci).Medtronic export ap aspiration catheter was used to perform mechanical thrombectomy on three patients in this group.One patient, who had a delayed presentation complicated by ventricular septal and free-wall rupture, died in the hospital.The other 32 patients survived their hospital stays.Of the six patients with a culprit lesion and covid-19, five presented to hospital with chest pain, two had cs, one had fever, one needed intubation, and one under went iabp placement.All six patients underwent pci, of which thrombectomy was performed in three patients; one using the medtronic export ap aspiration catheter and two using a non-medtronic aspiration catheter.One patient in this subgroup had very late right coronary artery stent thrombosis, profound lymphopenia and raised crp and d-dimer levels.This patient and one other in this group died in hospital.None of the four patients in the group with covid-19 without a culprit lesion underwent pci or had a medtronic device used on them.

Manufacturer Narrative

Journal article: atypical st-segment-elevation myocardial infarction presentation in patients with covid-19 at a highvolume center in new york city authors: miguel a.Alvarez villela, ahmad alkhalil, michael a.Weinreich, jonathan koslowsky, shunsuke aoi, m.Azeem latib journal: texas heart institute journal year: 2021 reference: doi: 10.14503/thij-20-7446 patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the death(s) was provided average age, majority gender, and date of publication.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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13658068
• MDR Text Key: 290575712
• Report Number: 1220452-2022-00019
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2022

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: 02/09/2022
• Initial Date FDA Received: 03/03/2022
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American