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

Model Number UNK634

Device Problem Obstruction of Flow (2423)

Patient Problems Chest Pain (1776); ST Segment Elevation (2059); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

Dr.Duygu ersan demirci, "simultaneous subacute thrombosis in two new-generation drug-eluting stents in different vessels," www.Anatoljcardiol.Com.Doi:10.14744/anatoljcardiol.2017.8092.Device is combination product.Device evaluated by mfr: the complaint device was not received for analysis.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

Same case as mdr# 2134265-2018-06964 and 2134265-2018-06963.It was reported via journal article that severe chest pain and subacute stent thrombosis occurred.The patient was admitted to the emergency department complaining of acute, severe chest pain.An emergent catheterization was performed, revealing a totally occluded proximal right coronary artery (rca) and a critical thrombotic lesion on the left circumflex artery (lcx).Angioplasty was performed and two everolimus-eluting stents (promus element, 2.5x16 mm and 2.5x20 mm) were deployed in the proximal rca and one everolimus-eluting stent (promus element, 3.0 x24 mm ) in the mid lcx.A final coronary angiography showed patency of the 2 vessels with timi-3 flow.The patient was discharged on hospital day three with a recommended course of treatment of dual antiplatelet therapy.After ten days, the patient was readmitted to the emergency department with severe chest pain.Electrocardiography revealed inferoposterior st segment elevation.The patient indicated he had stopped taking ticagrelor therapy three days earlier because of hematuria.He was hemodynamically stable and taken to the catheterization laboratory for primary percutaneous coronary intervention (pci), which revealed totally occluded proximal rca and mid lcx at the same time, the site of the stents.Successful primary pci with angioplasty was performed for both vessels with transradial access and a final angiography revealed timi-3 flow distal to the coronary stents.After four days of observation, the patient was discharged with a strict recommendation to continue dual antiplatelet therapy for at least one year.Simultaneous stent thrombosis in different new-generation drug eluting stents in multiple coronary vessels was extremely rare, but still a possible complication of pci.This case strongly suggests that it be ensured that patients are properly educated about the importance of drug use and the potential severe consequences of antiplatelet therapy cessation.Our case also demonstrates that the use of multiple stents, irrespective of stent type, in multiple coronary artery lesions should be undertaken with great attention, especially in high-risk patients, such as acute myocardial infarction.

Manufacturer Narrative

Upn corrected from unk717 to unk634.Upn search corrected from unk717 - promus element plus - cmc - maple grove (intervent cardio) - 30000 to unk634 - promus element - cmc - maple grove (intervent cardio) - interv cardiology - 30000.(b)(4).

Event Description

Same case as mdr# 2134265-2018-06964 and 2134265-2018-06963.It was reported via journal article that severe chest pain and subacute stent thrombosis occurred.The patient was admitted to the emergency department complaining of acute, severe chest pain.An emergent catheterization was performed, revealing a totally occluded proximal right coronary artery (rca) and a critical thrombotic lesion on the left circumflex artery (lcx).Angioplasty was performed and two everolimus-eluting stents (promus element, 2.5x16 mm and 2.5x20 mm) were deployed in the proximal rca and one everolimus-eluting stent (promus element, 3.0 x24 mm ) in the mid lcx.A final coronary angiography showed patency of the 2 vessels with timi-3 flow.The patient was discharged on hospital day three with a recommended course of treatment of dual antiplatelet therapy.After ten days, the patient was readmitted to the emergency department with severe chest pain.Electrocardiography revealed inferoposterior st segment elevation.The patient indicated he had stopped taking ticagrelor therapy thee days earlier because of hematuria.He was hemodynamically stable and taken to the catheterization laboratory for primary percutaneous coronary intervention (pci), which revealed totally occluded proximal rca and mid lcx at the same time, the site of the stents.Successful primary pci with angioplasty was performed for both vessels with transradial access and a final angiography revealed timi-3 flow distal to the coronary stents.After four days of observation, the patient was discharged with a strict recommendation to continue dual antiplatelet therapy for at least one year.Simultaneous stent thrombosis in different new-generation drug eluting stents in multiple coronary vessels was extremely rare, but still a possible complication of pci.This case strongly suggests that it be ensured that patients are properly educated about the importance of drug use and the potential severe consequences of antiplatelet therapy cessation.Our case also demonstrates that the use of multiple stents, irrespective of stent type, in multiple coronary artery lesions should be undertaken with great attention, especially in high-risk patients, such as acute myocardial infarction.

• Brand Name: PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7740391
• MDR Text Key: 115728624
• Report Number: 2134265-2018-07024
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• 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: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK634
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR