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

Model Number 9384

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

Patient Problem Reocclusion (1985)

Event Date 06/12/2016

Event Type  Injury  

Manufacturer Narrative

Devie is a combination product.

Event Description

(b)(6) clinical study.It was reported that the subject experienced acute coronary syndrome.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) 2016, 609 days post index procedure, the subject was diagnosed with acute coronary syndrome and was hospitalized for further treatment.Eight days later, the event was considered recovered/resolved and the subject was discharged.In (b)(6) 2019, 1710 days post index procedure, the lesion was treated with percutaneous coronary intervention.Residual stenosis was 0% with timi flow of 3.

Event Description

Promus element china clinical study.It was reported that the subject experienced acute coronary syndrome.(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.(b)(6) 2016, 609 days post index procedure, the subject was diagnosed with acute coronary syndrome and was hospitalized for further treatment.Eight days later, the event was considered recovered/resolved and the subject was discharged.(b)(6) 2019, 1710 days post index procedure, the lesion was treated with percutaneous coronary intervention.Residual stenosis was 0% with timi flow of 3.It was further reported that in (b)(6) 2016, angiography revealed 85% stenosis in the 2nd obtuse marginal artery (ob marg/om2), 90% stenosis in the 1st ob marg (om1) and distal rca.The pci was performed to lcx and rca; the exact region of the lcx was om1 and om2 which were branches of the lcx hence the causality for lcx was not related to the study device implanted in the lcx.Two days later, the event was considered recovered/resolved and the subject was discharged.

• 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: 9588173
• MDR Text Key: 175285225
• Report Number: 2134265-2020-00106
• 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: 10/13/2020

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: 08/15/2015
• Device Model Number: 9384
• Device Catalogue Number: 9384
• Device Lot Number: 0016847726
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 61 YR