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 Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 10/05/2021

Event Type  Injury  

Manufacturer Narrative

Title of the article: thin-strut bioresorbable-polymer sirolimus-eluting stent use for an optimal result of rescue coronary angioplasty in acute myocardial infarction failed thrombolytic therapy: the bangladesh national heart foundation annual conference oct-assisted live case year: 2021 reference: doi: 10.5114/aic.2021.109834 b3: date of publication if information is provided in the future, a supplemental report will be issued.

Event Description

A jornal article was submitted for review titled; thin-strut bioresorbable-polymer sirolimus-eluting stent use for an optimal result of rescue coronary angioplasty in acute myocardial infarction failed thrombolytic therapy: the bangladesh national heart foundation annual conference oct-assisted live case.The article described a case where a patient presented with stemi.The patient was treated with medication, however severe chest pain persisted.Ecg showed persistent st segment elevation.Coronary angiography showed a proximal left anterior descending (lad) coronary artery occlusion.After vessel wiring, thrombus aspiration was performed using export 6f aspiration catheter, red and white thrombi was successfully removed.Imaging visualized residual red thrombus, ruptured plaque, and white thrombus.A novel thin-strut non medtronic stent 3.0 × 18 mm was implanted directly with a single inflation at 10¿12 atm (30 s) with an optimal angiographic result and lack of any distal embolism.Imaging demonstrated an optimal reconstruction of the lumen in absence of any dissection and in absence of any in-stent thrombotic or plaque material.Three days later the patient was discharged home in good clinical condition.

• 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: 13579491
• MDR Text Key: 288815346
• Report Number: 1220452-2022-00018
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: BG
• PMA/PMN Number: K040869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2022

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
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/22/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male