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

Model Number 9392

Device Problem Obstruction of Flow (2423)

Patient Problems Myocardial Infarction (1969); Reocclusion (1985); Restenosis (4576)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

(b)(6) study.It was reported that in-stent restenosis and coronary disease occurred.In (b)(6) 2014, the patient was referred for unstable angina.On the same day, index procedure was performed.The target lesion was located in proximal left anterior descending (lad) artery extending up to mid lad artery with 85% stenosis and was 28mm long with a reference vessel diameter of 3.5mm.Pre-dilatation was performed with unknown balloon catheter and placement of a 3.50 x 32mm promus element study stent.Following post dilatation, residual stenosis was 0%.Six days after, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2018, post procedure the patient was diagnosed with coronary disease, stent restenosis.The patient was hospitalized on (b)(6) 2018.Third day after, coronary angiography was performed which revealed, mid lad 80% on-stent restenosis of previously placed study stent.On the same day, post index procedure, the 80% in-stent restenosis noted in mid lad was treated with percutaneous coronary intervention.Following intervention, residual stenosis was 30%.Four days after, the event was recovered/resolved and the patient was discharged.

Manufacturer Narrative

Device is a combination product date of event corrected from (b)(6) 2018 to (b)(6) 2018.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/13/2018 04:12 pm ct.The report number is being corrected from: 2134265-2018-64158 to: 2134265-2018-63009.

Event Description

Promus element china clinical study it was reported that in-stent restenosis and coronary disease occurred.In (b)(6) 2014, the patient was referred for unstable angina.On the same day, index procedure was performed.The target lesion was located in proximal left anterior descending (lad) artery extending up to mid lad artery with 85% stenosis and was 28mm long with a reference vessel diameter of 3.5mm.Pre-dilatation was performed with unknown balloon catheter and placement of a 3.50 x 32mm promus element study stent.Following post dilatation, residual stenosis was 0%.Six days after, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2018, post procedure the patient was diagnosed with coronary disease, stent restenosis.The patient was hospitalized on (b)(6) 2018.Third day after, coronary angiography was performed which revealed, mid lad 80% on-stent restenosis of previously placed study stent.On the same day, post index procedure, the 80% in-stent restenosis noted in mid lad was treated with percutaneous coronary intervention.Following intervention, residual stenosis was 30%.Four days after, the event was recovered/resolved and the patient was discharged.It was further reported that in (b)(6) 2018, the patient was diagnosed with coronary disease, stent restenosis.Six days later, coronary angiography was performed which revealed, mid lad 80% on-stent restenosis of previously placed study stent.On the same day, the 80% in-stent restenosis noted in mid lad was treated with percutaneous coronary intervention.Following intervention, residual stenosis was 30%.Four days after, the event was recovered/resolved and the patient was discharged.

Event Description

Promus element china clinical study: it was reported that in-stent restenosis and coronary disease occurred.In (b)(6) 2014, the patient was referred for unstable angina.On the same day, index procedure was performed.The target lesion was located in proximal left anterior descending (lad) artery extending up to mid lad artery with 85% stenosis and was 28mm long with a reference vessel diameter of 3.5mm.Pre-dilatation was performed with unknown balloon catheter and placement of a 3.50 x 32mm promus element study stent.Following post dilatation, residual stenosis was 0%.Six days after, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2018, post procedure the patient was diagnosed with coronary disease, stent restenosis.The patient was hospitalized on (b)(6) 2018.Third day after, coronary angiography was performed which revealed, mid lad 80% on-stent restenosis of previously placed study stent.On the same day, post index procedure, the 80% in-stent restenosis noted in mid lad was treated with percutaneous coronary intervention.Following intervention, residual stenosis was 30%.Four days after, the event was recovered/resolved and the patient was discharged.It was further reported that in (b)(6) 2018, the patient was diagnosed with acute myocardial infarction and target vessel revascularization (tvr) was performed.

Event Description

Promus element china clinical study.It was reported that in-stent restenosis and coronary disease occurred.In (b)(6) 2014, the patient was referred for unstable angina.On the same day, index procedure was performed.The target lesion was located in proximal left anterior descending (lad) artery extending up to mid lad artery with 85% stenosis and was 28mm long with a reference vessel diameter of 3.5mm.Pre-dilatation was performed with unknown balloon catheter and placement of a 3.50 x 32mm promus element study stent.Following post dilatation, residual stenosis was 0%.Six days after, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2018, post procedure the patient was diagnosed with coronary disease, stent restenosis.The patient was hospitalized on (b)(6) 2018.Third day after, coronary angiography was performed which revealed, mid lad 80% on-stent restenosis of previously placed study stent.On the same day, post index procedure, the 80% in-stent restenosis noted in mid lad was treated with percutaneous coronary intervention.Following intervention, residual stenosis was 30%.Four days after, the event was recovered/resolved and the patient was discharged.It was further reported that in (b)(6) 2018, the patient was diagnosed with acute myocardial infarction (mi) and target vessel revascularization (tvr) was performed.It was further reported that in (b)(6) 2018, the location of the mi was anterior (septal) and 12-lead electrocadiogram (ecg) was performed on the same day.

Event Description

Promus element china clinical study.It was reported that in-stent restenosis and coronary disease occurred.In (b)(6) 2014, the patient was referred for unstable angina.On the same day, index procedure was performed.The target lesion was located in proximal left anterior descending (lad) artery extending up to mid lad artery with 85% stenosis and was 28mm long with a reference vessel diameter of 3.5mm.Pre-dilatation was performed with unknown balloon catheter and placement of a 3.50 x 32mm promus element study stent.Following post dilatation, residual stenosis was 0%.Six days after, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2018, post procedure the patient was diagnosed with coronary disease, stent restenosis.The patient was hospitalized on (b)(6) 2018.Third day after, coronary angiography was performed which revealed, mid lad 80% on-stent restenosis of previously placed study stent.On the same day, post index procedure, the 80% in-stent restenosis noted in mid lad was treated with percutaneous coronary intervention.Following intervention, residual stenosis was 30%.Four days after, the event was recovered/resolved and the patient was discharged.It was further reported that in (b)(6) 2018, the patient was diagnosed with acute myocardial infarction and target vessel revascularization (tvr) was performed.It was further reported that in (b)(6) 2018, the location of the mi was anterior (septal) and 12-lead electrocadiogram (ecg) was performed on the same day.It was further reported that in (b)(6) 2018, the patient was diagnosed with coronary disease and hospitalized on the same day for further evaluation and treatment.Sixth day after, the patient was referred for coronary angiography and treated with pci.It was previously reported that the subject was diagnosed with acute mi.However, the event would not qualify for the clinical event committee (cec) of mi, therefore, the diagnosis of mi was withdrawn.

Manufacturer Narrative

Corrected: (h6) patient codes: removed myocardial infarction e061202.

• 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: 8095927
• MDR Text Key: 128095532
• Report Number: 2134265-2018-63009
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P11010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2015
• Device Model Number: 9392
• Device Catalogue Number: 9392
• Device Lot Number: 0016898984
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR