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

Model Number 9554

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

Patient Problems Myocardial Infarction (1969); Reocclusion (1985); Complaint, Ill-Defined (2331); Restenosis (4576)

Event Date 09/02/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name: (b)(6) hospital.

Event Description

(b)(6) registry it was reported that acute coronary syndrome occurred.In (b)(6) 2019, the subject was referred for cardiac catheterization and index procedure was performed on the same day.The target lesion was located in the mid right coronary artery(rca) with 90% stenosis and was 34mm long and a reference vessel diameter of 2.75mm.The lesion was treated with pre-dilatation and placement of a 2.75mmx38mm promus premier drug-eluting stent.Following post dilatation was performed with 10% residual stenosis.Five days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2019, the subject presented with symptoms related to acute coronary syndrome (acs) and was hospitalized for further evaluation and treatment.The subject was diagnosed with acs and no other action was taken to treat the event.Two weeks later, the event was considered recovered/resolved and on the same day, the subject was discharged on aspirin and clopidogrel.No other information is available at this point of time.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).

Event Description

Promus premier china registry: it was reported that acute coronary syndrome occurred.In (b)(6) 2019, the subject was referred for cardiac catheterization and index procedure was performed on the same day.The target lesion was located in the mid right coronary artery(rca) with 90% stenosis and was 34mm long and a reference vessel diameter of 2.75mm.The lesion was treated with pre-dilatation and placement of a 2.75mmx38mm promus premier drug-eluting stent.Following post dilatation was performed with 10% residual stenosis.Five days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2019, the subject presented with symptoms related to acute coronary syndrome (acs) and was hospitalized for further evaluation and treatment.The subject was diagnosed with acs and no other action was taken to treat the event.Two weeks later, the event was considered recovered/resolved and on the same day, the subject was discharged on aspirin and clopidogrel.No other information is available at this point of time.It was further reported that in (b)(6) 2019, the subject was referred for coronary angiography which revealed 100% stenosis in mid rca.The subject was treated with percutaneous coronary intervention/target-vessel revascularization(tvr).Post intervention, residual stenosis was 10%.

Event Description

Promus premier china registry.It was reported that acute coronary syndrome occurred.In (b)(6) 2019, the subject was referred for cardiac catheterization and index procedure was performed on the same day.The target lesion was located in the mid right coronary artery(rca) with 90% stenosis and was 34mm long and a reference vessel diameter of 2.75mm.The lesion was treated with pre-dilatation and placement of a 2.75mmx38mm promus premier drug-eluting stent.Following post dilatation was performed with 10% residual stenosis.Five days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2019, the subject presented with symptoms related to acute coronary syndrome (acs) and was hospitalized for further evaluation and treatment.The subject was diagnosed with acs and no other action was taken to treat the event.Two weeks later, the event was considered recovered/resolved and on the same day, the subject was discharged on aspirin and clopidogrel.No other information is available at this point of time.It was further reported that in (b)(6) 2019, the subject was referred for coronary angiography which revealed 100% stenosis in mid rca.The subject was treated with percutaneous coronary intervention/target-vessel revascularization(tvr).Post intervention, residual stenosis was 10%.It was further reported that in (b)(6) 2019, the subject presented with myocardial infarction (mi) and a 12-lead electrocardiogram (ecg) was performed.On the following day, cardiac enzymes noted with peak ck-mb = 44 iu/l; uln= 24 iu/l and peak ck total = 381 iu/l; uln= 130 iu/l.The subject was diagnosed with mi based on angiography and ecg changes.Location of mi was inferior.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10858633
• MDR Text Key: 216842017
• Report Number: 2134265-2020-15989
• 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: 03/17/2021

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 Date: 09/04/2020
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0022645355
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 11/25/2020; 03/05/2021
• Supplement Dates FDA Received: 12/15/2020; 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 74 YR