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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC CORPORATION SYNERGY CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Thrombosis (2100)
Event Date 11/23/2019
Event Type  Death  
Manufacturer Narrative

Device is a combination product. Implant date: 2016. Initial reporter city: (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.

 
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Brand NameSYNERGY
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9427712
MDR Text Key169555960
Report Number2134265-2019-15020
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
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 Received12/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/06/2019 Patient Sequence Number: 1
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