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

Model Number 9384

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

Patient Problems Atherosclerosis (1728); Myocardial Infarction (1969); No Code Available (3191)

Event Date 04/29/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

(b)(6) clinical study.It was reported that myocardial infarction and atherosclerosis occurred.In (b)(6) 2014, the subject presented with unstable angina and was referred for cardiac catheterization.Subsequently, the index procedure was performed.The subject received heparin or other anti-thrombin medication.The target lesion #1 was located in the distal right coronary artery (rca) with 90% stenosis and was 15 mm long, with a reference vessel diameter of 2.5 mm.The lesion was treated with pre-dilatation and placement of a 2.50x16mm promus element stent with 10% of stenosis.Post dilatation was not performed.The target lesion #2 was located in the proximal (rca) with 80% stenosis and was 15 mm long, with a reference vessel diameter of 3.0 mm.The lesion was treated with pre-dilatation and placement of a 3.00x16mm promus element stent with 10% of stenosis.Post dilatation was not performed.The target lesion #3 was located in the proximal left circumflex (lcx) artery with 99% stenosis and was 16 mm long, with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.50x16mm promus element stent with 10% of stenosis.Post dilatation was not performed.Six days later, the subject was discharged on aspirin, clopidogrel and ticagrelor.In (b)(6) 2017, the subject was diagnosed with coronary atherosclerotic heart disease.On the same day, the subject was hospitalized for further treatment.On the same day angiography was performed and revealed 100% diameter stenosis in the prox rca to the mid rca with timi flow of 0, hence a pci was performed to the lesions.Post pci, there was 0% stenosis with timi flow of 3.In (b)(6) 2017, three days post procedure, the event was considered recovered/resolved and the subject was discharged.

Event Description

Promus element china clinical study.It was reported that myocardial infarction and atherosclerosis occurred.In (b)(6) 2014, the subject presented with unstable angina and was referred for cardiac catheterization.Subsequently, the index procedure was performed.The subject received heparin or other anti-thrombin medication.The target lesion #1 was located in the distal right coronary artery (rca) with 90% stenosis and was 15 mm long, with a reference vessel diameter of 2.5 mm.The lesion was treated with pre-dilatation and placement of a 2.50x16mm promus element stent with 10% of stenosis.Post dilatation was not performed.The target lesion #2 was located in the proximal (rca) with 80% stenosis and was 15 mm long, with a reference vessel diameter of 3.0 mm.The lesion was treated with pre-dilatation and placement of a 3.00x16mm promus element stent with 10% of stenosis.Post dilatation was not performed.The target lesion #3 was located in the proximal left circumflex (lcx) artery with 99% stenosis and was 16 mm long, with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.50x16mm promus element stent with 10% of stenosis.Post dilatation was not performed.Six days later, the subject was discharged on aspirin, clopidogrel and ticagrelor.In (b)(6) 2017, the subject was diagnosed with coronary atherosclerotic heart disease.On the same day, the subject was hospitalized for further treatment.On the same day angiography was performed and revealed 100% diameter stenosis in the prox rca to the mid rca with timi flow of 0, hence a pci was performed to the lesions.Post pci, there was 0% stenosis with timi flow of 3.(b)(6) 2017, three days post procedure, the event was considered recovered/resolved and the subject was discharged.It was further reported that in (b)(6) 2017, the subject was diagnosed with non-st-elevation myocardial infarction.

Event Description

Promus element china clinical study.It was reported that myocardial infarction and atherosclerosis occurred.In (b)(6) 2014, the subject presented with unstable angina and was referred for cardiac catheterization.Subsequently, the index procedure was performed.The subject received heparin or other anti-thrombin medication.The target lesion #1 was located in the distal right coronary artery (rca) with 90% stenosis and was 15 mm long, with a reference vessel diameter of 2.5 mm.The lesion was treated with pre-dilatation and placement of a 2.50x16mm promus element stent with 10% of stenosis.Post dilatation was not performed.The target lesion #2 was located in the proximal (rca) with 80% stenosis and was 15 mm long, with a reference vessel diameter of 3.0 mm.The lesion was treated with pre-dilatation and placement of a 3.00x16mm promus element stent with 10% of stenosis.Post dilatation was not performed.The target lesion #3 was located in the proximal left circumflex (lcx) artery with 99% stenosis and was 16 mm long, with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.50x16mm promus element stent with 10% of stenosis.Post dilatation was not performed.Six days later, the subject was discharged on aspirin, clopidogrel and ticagrelor.In (b)(6) 2017, the subject was diagnosed with coronary atherosclerotic heart disease.On the same day, the subject was hospitalized for further treatment.On the same day angiography was performed and revealed 100% diameter stenosis in the prox rca to the mid rca with timi flow of 0, hence a pci was performed to the lesions.Post pci, there was 0% stenosis with timi flow of 3.(b)(6) 2017, three days post procedure, the event was considered recovered/resolved and the subject was discharged.It was further reported that in (b)(6) 2014, the subject presented with unstable angina and was referred for cardiac catheterization.The index procedure was performed the same day.Target lesion #1 was located in the distal right coronary artery (rca) with 90% stenosis and was 15 mm long, with a reference vessel diameter of 2.5 mm.The lesion was treated with pre-dilatation and placement of a 2.50x16mm promus element stent with 0% residual stenosis.Post dilatation was not performed.Target lesion #2 was located in the proximal rca with 80% stenosis and was 15 mm long, with a reference vessel diameter of 3.0 mm.The lesion was treated with pre-dilatation and placement of a 3.00x16mm promus element stent with 0% residual stenosis.Post dilatation was not performed.Target lesion #3 was located in the proximal left circumflex (lcx) artery with 99% stenosis and was 16 mm long, with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.50x16mm promus element stent with 0% residual stenosis.Post dilatation was not performed.Six days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2017, during a routine follow up visit, the subject presented with unknown symptoms of myocardial infarction (mi) and was hospitalized for further treatment.On the same day cardiac enzymes were elevated which was consistent with protocol definition of mi with peak troponin of 0.019 ng/ml.An electrocardiogram revealed an inferior non-st-elevation mi.Angiography was then performed which revealed 100% stenosis in the proximal to distal rca which was treated with percutaneous coronary intervention (pci) with 0% residual stenosis.The event was also treated medically.(b)(6) 2017, three days post procedure, the event was considered recovered/resolved and the subject was discharged.

• Brand Name: PROMUS ELEMENT PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9589568
• MDR Text Key: 175907942
• Report Number: 2134265-2020-00118
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2015
• Device Model Number: 9384
• Device Catalogue Number: 9384
• Device Lot Number: 0016840826
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 61 YR