MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING

Model Number 9551

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 02/18/2023

Event Type  Injury  

Event Description

Promus premier china registry.It was reported that a myocardial infarction and restenosis occurred.In (b)(6) 2019, the subject presented with unstable angina (braunwald classification- unknown) and was referred for cardiac catheterization.The target lesion was located in the proximal right coronary artery (rca) extended up to middle rca with 80% stenosis and was 20 mm long, with a reference vessel diameter of 4.00 mm.The target lesion was treated with pre-dilatation and placement of a 4.00 mm x 24 mm promus premier stent system.Following post dilatation, the residual stenosis was noted to be 0%.The subject was discharged on aspirin and clopidogrel.In february 2023, during follow-up visit the subject was diagnosed with acute myocardium infarction and was hospitalized on the same day for further evaluation and treatment.In the same day, the subject was referred for coronary angiography which revealed that the unknown % stenosis noted in proximal rca.The unknown % stenosis noted in proximal rca which had previously placed study device was treated with percutaneous coronary intervention.Post procedure, percent diameter stenosis was noted to be 0%.Additionally, medications were adjusted to treat the event.In june 2023, the event was considered to be recovered/resolved and the subject was discharged on the same day on aspirin and clopidogrel.

Event Description

Promus premier china registry it was reported that a myocardial infarction and restenosis occurred.In march 2019, the subject presented with unstable angina (braunwald classification- unknown) and was referred for cardiac catheterization.The target lesion was located in the proximal right coronary artery (rca) extended up to middle rca with 80% stenosis and was 20 mm long, with a reference vessel diameter of 4.00 mm.The target lesion was treated with pre-dilatation and placement of a 4.00 mm x 24 mm promus premier stent system.Following post dilatation, the residual stenosis was noted to be 0%.The subject was discharged on aspirin and clopidogrel.In february 2023, during follow-up visit the subject was diagnosed with acute myocardium infarction and was hospitalized on the same day for further evaluation and treatment.In the same day, the subject was referred for coronary angiography which revealed that the unknown % stenosis noted in proximal rca.The unknown % stenosis noted in proximal rca which had previously placed study device was treated with percutaneous coronary intervention.Post procedure, percent diameter stenosis was noted to be 0%.Additionally, medications were adjusted to treat the event.In june 2023, the event was considered to be recovered/resolved and the subject was discharged on the same day on aspirin and clopidogrel.It was further reported that the subject experienced proximal stent thrombosis and was diagnosed with acute myocardial infarction in february 2023.The location of myocardial infarction was anterior (septal) and was not identifiable.

Event Description

Promus premier china registry it was reported that a myocardial infarction and restenosis occurred.In (b)(6) 2019, the subject presented with unstable angina (braunwald classification- unknown) and was referred for cardiac catheterization.The target lesion was located in the proximal right coronary artery (rca) extended up to middle rca with 80% stenosis and was 20 mm long, with a reference vessel diameter of 4.00 mm.The target lesion was treated with pre-dilatation and placement of a 4.00 mm x 24 mm promus premier stent system.Following post dilatation, the residual stenosis was noted to be 0%.The subject was discharged on aspirin and clopidogrel.In (b)(6) 2023, during follow-up visit the subject was diagnosed with acute myocardium infarction and was hospitalized on the same day for further evaluation and treatment.In the same day, the subject was referred for coronary angiography which revealed that the unknown % stenosis noted in proximal rca.The unknown % stenosis noted in proximal rca which had previously placed study device was treated with percutaneous coronary intervention.Post procedure, percent diameter stenosis was noted to be 0%.Additionally, medications were adjusted to treat the event.In (b)(6) 2023, the event was considered to be recovered/resolved and the subject was discharged on the same day on aspirin and clopidogrel.It was further reported that the subject experienced proximal stent thrombosis and was diagnosed with acute myocardial infarction in (b)(6) 2023.The location of myocardial infarction was anterior (septal) and was not identifiable.It was further reported that the 100 % stenosis noted in proximal rca in (b)(6) 2023.The location of mi was not identifiable, and it is unknown whether it was q-wave or non-q-wave.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17573940
• MDR Text Key: 321450201
• Report Number: 2124215-2023-42043
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9551
• Device Catalogue Number: 9551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 44 YR
• Patient Sex: Male