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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10623
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Ischemia (1942)
Event Date 03/08/2022
Event Type  Death  
Event Description
It was reported that a patient death occurred. The first target lesion was located in the right coronary artery (rca) and the second lesion in the left main coronary artery (lmca). A 2. 50 x 38 synergy drug eluting stent and a 2. 75 x 20 synergy drug eluting stent were deployed to treat the lesions. Following the deployments, a proximal optimization technique (pot) was performed in the left main (lm). Afterward, while re-crossing, the left circumflex (lcx) occluded and the patient experienced hypotension and bradycardia. Despite administration of medications and support with intra aortic balloon pump (iabp), the patient was unable to revive, ultimately resulting in the patient passing away. It was further reported that the patient presented with triple vessel disease with left main disease. The left circumflex became occluded while re-crossing the wire and no flow occurred. The physician assessment was that there was no relationship to the patient death and the devices used.
 
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Brand NameSYNERGY
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13939719
MDR Text Key288117622
Report Number2134265-2022-03614
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10623
Device Catalogue Number10623
Device Lot Number0027754941
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/20/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/29/2022 Patient Sequence Number: 1
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