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

Model Number 9309

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

Patient Problems Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 12/24/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

(b)(6) clinical study.It was reported that myocardial infarction occurred.In (b)(6) 2014, the subject was referred for cardiac catheterization.The target lesion was a long lesion located in mid left anterior descending artery (lad) extending to proximal lad with 100% stenosis, a length of 48mm, and a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of 3.00 x 28 mm and 3.50 x 24 mm promus element stents.Following post dilatation, the residual stenosis was 0%.Eleven days after, the subject was scheduled for staged procedure.The target lesion was located in the proximal right coronary artery with 80% stenosis, a length of 44 mm, and a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of 3.00 x 16 mm and 2.75 x 32 mm promus element stents.Following post dilatation, the residual stenosis was 0%.Three days later, the patient was discharged on aspirin and ticagrelor.In (b)(6) 2018, the subject was diagnosed with acute st segment elevation myocardial infarction and was hospitalized.Coronary angiography revealed stenosis at the mid lad.Percutaneous coronary intervention was performed on the lad and left circumflex artery.Residual stenosis was unknown.The event was considered resolving.

Event Description

Promus element china clinical study it was reported the subject experienced st segment elevation, myocardial infarction and target vessel restenosis.In (b)(6) 2014, the subject was referred for cardiac catheterization.The target lesion was a long lesion located in the mid left anterior descending artery (lad) extending to proximal lad with 100% stenosis, a length of 48mm, and a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 28 mm and 3.50 x 24 mm promus element stents.Following post dilatation, the residual stenosis was 0%.Eleven days later, the subject was scheduled for a staged procedure and performed on the same day.The target lesion was located in the proximal right coronary artery (rca) with 80% stenosis, a length of 44 mm, and a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 16 mm and 2.75 x 32 mm promus element stents.Following post dilatation, the residual stenosis was 0%.Three days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2018, 1512 days post index procedure and 1501 days post staged procedure, the subject was diagnosed with acute st segment elevation myocardial infarction and was hospitalized.Coronary angiography revealed stenosis at the mid lad.Percutaneous coronary intervention was performed on the lad and left circumflex artery.Residual stenosis was unknown.The event was considered resolving.It was further reported that in (b)(6) 2018, 12 lead electrocardiogram was performed.Cardiac enzyme elevation was consistent with protocol definition of mi, with ck-mb= 14.35 ng/ml, uln value= 6.3 ng/ml: and troponin=0.38 ng/ml, uln value=0.014 ng/ml.Furthermore, on the next day, cardiac enzyme elevated with ck-mb=96.18 ng/ml; uln value= 6.3 ng/ml and troponin=31.49 ng/ml, uln value=0.014 ng/ml.An event of stent thrombosis with 100% stenosis in mid lad was also reported.In (b)(6) 2019, the subject was discharged.

• Brand Name: PROMUS ELEMENT
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8497273
• MDR Text Key: 141386651
• Report Number: 2134265-2019-03485
• 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
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2015
• Device Model Number: 9309
• Device Catalogue Number: 9309
• Device Lot Number: 0016666851
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR