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)

Event Date 05/18/2019

Event Type  Injury  

Manufacturer Narrative

Device is combination product.

Event Description

(b)(6) clinical study.It was reported that in-stent restenosis occurred.In (b)(6) 2014, the subject presented with unstable angina and was referred for cardiac catheterization on the same day.The target lesion was located in the proximal left anterior descending artery (lad) extending up to middle lad with 85% stenosis, and was 28 mm long with a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of a 3.50 x 32 mm promus element plus drug-eluting stent with 0% residual stenosis.Six days later, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2019, 1670 days post index procedure, the patient was diagnosed with coronary disease and was hospitalized on the same day.Nine days later, coronary angiography was performed which revealed, the proximal lad 80% in-stent restenosis of previously place study device.The restenosis was treated with percutaneous coronary intervention with residual stenosis of 0%.Four days later, the event was considered to be recovered/resolved, and the subject was discharged on the same day.

Manufacturer Narrative

Device is combination product.

Event Description

Promus element china clinical study it was reported that in-stent restenosis occurred.In (b)(6)2014 , the subject presented with unstable angina and was referred for cardiac catheterization on the same day.The target lesion was located in the proximal left anterior descending artery (lad) extending up to middle lad with 85% stenosis, and was 28 mm long with a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of a 3.50 x 32 mm promus element plus drug-eluting stent with 0% residual stenosis.Six days later, the patient was discharged on aspirin and clopidogrel.In (b)(6)2019 , 1670 days post index procedure, the patient was diagnosed with coronary disease and was hospitalized on the same day.Nine days later, coronary angiography was performed which revealed, the proximal lad 80% in-stent restenosis of previously place study device.The restenosis was treated with percutaneous coronary intervention with residual stenosis of 0%.Four days later, the event was considered to be recovered/resolved, and the subject was discharged on the same day.It was further reported that in may 2019, an anterior myocardial infarction was noted.Troponin t levels were elevated to 1.310 ng/ml (upper limit: 0-0.014 ng/ml), ck total level was 2055.00 iu/l (upper limit: 310 iu/l ) and ck-mb was 161.90 iu/l (upper limit: 25 iu/l ).Following intervention there was timi 3 flow.

• 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: 9420623
• MDR Text Key: 169680269
• Report Number: 2134265-2019-15136
• 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: 02/07/2020

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 Date: 09/06/2015
• Device Model Number: 9392
• Device Catalogue Number: 9392
• Device Lot Number: 0016898984
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR