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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT PLUS; STENT, CORONARY, DRUG-ELUTING Back to Search Results
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.
 
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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 Key9589568
MDR Text Key175907942
Report Number2134265-2020-00118
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/09/2015
Device Model Number9384
Device Catalogue Number9384
Device Lot Number0016840826
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/03/2020
Initial Date FDA Received01/14/2020
Supplement Dates Manufacturer Received09/30/2020
10/05/2020
Supplement Dates FDA Received10/07/2020
10/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age61 YR
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