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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 H7493919928350
Device Problem Occlusion Within Device (1423)
Patient Problems Chest Pain (1776); Headache (1880); Reocclusion (1985); Anxiety (2328); Diaphoresis (2452)
Event Date 11/15/2016
Event Type  Injury  
Manufacturer Narrative
Device is a combination product. Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental med watch will be filed. (b)(4).
 
Event Description
(b)(6) clinical study. It was reported that in-stent restenosis (isr) and chest pain occurred. In (b)(6) 2013, clinical assessment indicated the patient¿s qualifying condition as stable angina. Subsequently, the patient was referred for cardiac catheterization and index procedure was performed. The target lesion was located in the mid left anterior descending (lad) artery with 75% stenosis and was 20 mm long with a reference vessel diameter of 3. 5 mm. The target lesion was treated with pre-dilatation and placement of a 3. 50 x 28 mm study stent with residual stenosis was 0%. On the same day, the patient was discharge on dual antiplatelet therapy. In (b)(6) 2016, the patient presented with complaints of chest pain associated with diaphoresis, headaches and anxiety. The patient was referred for selective angiography and percutaneous coronary intervention. The 80% stenosis in the proximal lad also involving the proximal edge of the previously deployed stent in the mid lad and was treated with placement of 3. 5 x 12 mm promus premier drug eluting stent. Post stent deployment, the residual stenosis was 0% with timi 3 flow. On the following day, the patient was discharged on dual antiplatelet medication.
 
Manufacturer Narrative
(b)(6) 2016. (b)(4).
 
Event Description
It was further reported that in (b)(6) 2016, the patient was diagnosed with venous reflux. Electrocardiogram revealed sinus rhythm, left axis-anterior fasicular block, inferior-lateral infarct, and anterolateral st-elevation. The patient took sublingual nitroglycerin several times a weeks for chest discomfort.
 
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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 Key6241572
MDR Text Key64487585
Report Number2134265-2016-12455
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/16/2013
Device Model NumberH7493919928350
Device Lot Number15697628
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 Received05/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2012
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: 01/11/2017 Patient Sequence Number: 1
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