MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number 10618

Device Problem Obstruction of Flow (2423)

Patient Problems Death (1802); Thrombosis (2100)

Event Date 11/23/2019

Event Type  Death  

Manufacturer Narrative

Device is a combination product.(b)(6).

Event Description

It was reported that stent thrombosis and death occurred.In 2016, and unspecified synergy drug-eluting stent was implanted to treat a target lesion in the left anterior descending artery (lad).In (b)(6) 2019, the patient presented with thrombus occlusion around the synergy stent.Percutaneous coronary intervention (pci) was performed and a 2.50 x 16 synergy drug-eluting stent was placed, however, flow became worse and the patient was placed on intra-aortic balloon pump support.The next day, urgent coronary angiography was performed which revealed thrombus occlusion after the treated segment.After pci was performed, thrombus aspiration, pulse infusion thrombolysis and reperfusion/reflushing were also performed.The hemodynamics got worse so percutaneous cardiopulmonary support was inserted.As a result, the left ventricle ruptured and the patient passed away the next day.

Event Description

It was reported that stent thrombosis and death occurred.In 2016, an unspecified synergy drug-eluting stent was implanted to treat a target lesion in the left anterior descending artery (lad).In november 2019, the patient presented with thrombus occlusion around the synergy stent.Percutaneous coronary intervention (pci) was performed and a 2.50 x 16 synergy drug-eluting stent was placed, however, flow became worse and the patient was placed on intra-aortic balloon pump support.The next day, urgent coronary angiography was performed which revealed thrombus occlusion after the treated segment.After pci was performed, thrombus aspiration, pulse infusion thrombolysis and reperfusion/reflushing were also performed.The hemodynamics got worse so percutaneous cardiopulmonary support was inserted.As a result, the left ventricle ruptured and the patient passed away the next day.It was further reported that the patient had taken 75mg clopidogrel since january 2010.Along with the thrombus suction, dilatation was performed with a balloon catheter, an intra-aortic balloon pump (iabp) was inserted, and aspirin administration was started.Two days later, suction was attempted for the re-thrombus occlusion, however the left ventricle perforation occurred and the patient died.The physician considered patient condition to have caused the stent thrombosis and that there was no causal correlation between this device and the stent thrombosis and death.

Manufacturer Narrative

Device is a combination product.(b)(6).

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9427763
• MDR Text Key: 169557843
• Report Number: 2134265-2019-15019
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2020
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0023109044
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Weight: 60