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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT Back to Search Results
Device Problem Obstruction of Flow (2423)
Patient Problems Chest Pain (1776); Cardiac Enzyme Elevation (1838); Thrombosis/Thrombus (4440)
Event Date 03/01/2022
Event Type  Injury  
Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
 
Event Description
It was reported that acute stent thrombosis occurred.A 2.25x24 synergy xd drug eluting stent was implanted to treat a target lesion.Post stent implantation, stent thrombosis occurred, possibly due to the patient clotting disorder.The patient had pain prior to being removed off the table and when the pain was unresolved, an ekg was performed which revealed st-elevation.The patient was returned to the catheter lab and a wire with aggrastat was used to reinstate blood flow.No further complications were reported.
 
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Brand Name
SYNERGY XD
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key14116527
MDR Text Key289314077
Report Number2134265-2022-04424
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
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
Date Manufacturer Received03/29/2022
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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