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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - GALWAY SYNERGY¿ CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493926216400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Enzyme Elevation (1838); Fatigue (1849); Myocardial Infarction (1969); Pain (1994); Dizziness (2194)
Event Date 05/12/2017
Event Type  Injury  
Manufacturer Narrative
Age at time of event, age at time of event (unit), patient sex, describe event or problem, other relevant history, catalog/model #, device lot number, device expiration date, device manufactured date updated. (b)(4).
 
Event Description
It was further reported that in (b)(6) 2017, clinical status assessment indicated the patient's qualifying condition as stable angina and the index procedure was performed. The target lesion was located in the proximal left anterior descending (lad) artery with 90% stenosis and was 11mm long with a reference vessel diameter of 4. 0mm. The target lesion was treated with pre-dilatation and placement of a 4. 00 x 16 synergy¿ drug-eluting stent. Following post-dilatation, there was 5% residual stenosis. Three days later the patient was discharged on dual antiplatelet therapy.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that during the index procedure following post dilatation, the timi flow was 3. Post index procedure, the patient was ordered for repeat angiography, electrocardiogram (ecg) and lab examination. The patient was kept under clinical observation of pain and support. Ecg revealed no abnormalities. In addition, the patient also underwent coronary angiography which revealed occlusion of the diagonal branch. During the stay in the hospital, the patient was noted with fatigue associated with dizziness while walking. Three days later, the patient was found to be hemodynamically stable with improvement in pain and was discharged on antiplatelet therapy.
 
Manufacturer Narrative
Device is a combination product. The device was not received for analysis. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu. (b)(4).
 
Event Description
(b)(4) clinical study. It was reported that myocardial infarction (mi) occurred. In (b)(6) 2017, the index procedure was performed and a synergy¿ drug-eluting stent was implanted for treatment. However, post index procedure, cardiac enzymes were noted to be elevated and an event of periprocedure mi was reported. The outcome of the event is not recovered.
 
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Brand NameSYNERGY¿
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6602631
MDR Text Key108430172
Report Number2134265-2017-05629
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/15/2017
Device Model NumberH7493926216400
Device Catalogue Number39262-1640
Device Lot Number18953583
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 Received09/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/07/2016
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: 05/31/2017 Patient Sequence Number: 1
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