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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 10617
Device Problem Defective Device (2588)
Patient Problems Prolapse (2475); No Code Available (3191)
Event Date 08/28/2019
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that tissue / plaque prolapse occurred. A percutaneous coronary intervention was being performed on a lesion in the left main coronary artery. The lesion was predilated with 2. 5 mm balloon and then further predilated with a 3. 0 mm scoring balloon. A 4 mm x 12 mm synergy stent was then deployed at 12 atmospheres. Immediately after stent deployment, an abnormality in the middle of the stent was angiographically seen and seemed a plaque prolapse occurred. The synergy stent was post dilated with 4. 0 mm nc balloon at 15 atmospheres. After the post-dilatation it was observed angiographically that the in-stent abnormality had increased many folds. A 4 mm non-bsc drug eluding stent was then implanted. Per the user, it may have been a case of distortion of the stent struts or stent fracture, however this is not known. The patient was successfully discharged.
 
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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 Key9119325
MDR Text Key160154308
Report Number2134265-2019-11522
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 09/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/10/2019
Device Model Number10617
Device Catalogue Number10617
Device Lot Number0022162878
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 Received09/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/14/2018
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: 09/25/2019 Patient Sequence Number: 1
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