MAUDE Adverse Event Report: MEDTRONIC IRELAND ONYX FRONTIER; CORONARY DRUG-ELUTING STENT

Model Number ONYXNG27522X

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

Patient Problems Abdominal Pain (1685); Anemia (1706); Hematoma (1884); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 03/27/2024

Event Type  Injury  

Event Description

An attempt was made to use one onyx frontier coronary drug-eluting stent to treat a non-tortuous, non-calcified lesion in the mid left anterior descending (lad) artery.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The device passed through a previously deployed stent.Resistance was not encountered.Excessive force was not used during delivery.It was reported that a clinical adverse event occurred.It was detailed that the patient suffered an acute stent thrombosis 0-24 hours post stent implantation.The patient presented to hospital with chest pain two days prior to the event and had a history of radiating pain to left shoulder associated with palpitation and breathlessness.The patient was diagnosed with acute coronary syndrome (acs) and given loading dose tenecteplase injection.An electrocardiogram (ecg) showed st elevation, no echocardiographic regional wall motion abnormalities (rwma), adequate left ventricle (lv) function, mild pericardial effusion and troponin i was >25000pg/ml.The patient underwent a coronary artery angiography (cag) which revealed lad d2 bifurcation disease.The patient then underwent a percutaneous coronary intervention (pci) in the lad d2 bifurcation.The patient tolerated the procedure well and the post procedure period was uneventful.A rheumatologist and general physician were consulted regarding the patient¿s known systemic lupus erythematosus (sle) and anemia.One unit of packed red blood cells (prbcs) was transfused without any transfusion reactions.Hemoglobin (hb) was monitored.The patient had lower abdominal pain for which a contrast-enhanced computed tomography (cect) was done.A large pelvic extra-peritoneal hematoma on the right-side causing mass effect on the urinary bladder and a large sub-serosal fibroid of the uterus was seen.One unit of prbc and one unit of whole blood were transfused without reaction.The patient was given iv antibiotics, anticoagulants, antiplatelet, statin, beta-blocker, antianginal, steroid, ppi and other supportive measures.The patient became clinically better and was discharged.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Additional information: the stent was fully expanded and no issues were noted during stent deployment.The thrombus occurred immediately post procedure in the lad distal stent after the wire was taken out.The patient was on dapt when this thrombotic event occurred.The thrombus was treated by post dilation with a non compliant balloon.It was stated that it is not known if the thrombus event was directly related to the use of the medtronic device as the event occurred immediately post procedure.The patient is reported to be fine.Event date updated.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ONYX FRONTIER
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19171846
• MDR Text Key: 340908514
• Report Number: 9612164-2024-01960
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ONYXNG27522X
• Device Catalogue Number: ONYXNG27522X
• Device Lot Number: 0011997610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Date Device Manufactured: 10/16/2023
• 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): Other
• Patient Age: 47 YR
• Patient Sex: Female