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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 H7493926232220
Device Problem Occlusion Within Device (1423)
Patient Problems Chest Pain (1776); Hypersensitivity/Allergic reaction (1907); Reocclusion (1985)
Event Type  Injury  
Manufacturer Narrative
Age at time of event: (b)(6).Event date: (b)(6) 2016.Device is a combination product.The complaint device was not returned for analysis.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
 
Event Description
It was reported that chest pain, in-stent restenosis (isr), and allergic reaction occurred.In (b)(6) 2014, a non-bsc stent was implanted in the mid left anterior descending (lad) artery.In (b)(6) 2015, isr was found in the previously implanted stent and in response, dilatation was performed using a drug coated balloon (dcb).In (b)(6) 2016, isr was observed again which was treated with the implantation of a 2.25 x 32 synergy¿ drug-eluting stent.In (b)(6) 2016, the patient complained of chest pain and occlusion was found in the mid lad.It was noted that the patient also has a stent placed in the mid right coronary artery (rca).Since isr has been reoccurring, metal allergy was suspected.Metal patch test was performed and it was confirmed that the patient was allergic to six kinds of metal including nickel.In (b)(6) 2016, isr was observed again.It was determined that further stent placement would be difficult due to the recurring restenosis caused by the patient's metal allergy; therefore, coronary artery bypass grafting was performed.In (b)(6) 2017, patient was discharged from the hospital.No further patient complications were reported and the patient's status was stable.
 
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Brand Name
SYNERGY¿
Type of Device
CORONARY 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 Key7028915
MDR Text Key91939779
Report Number2134265-2017-11230
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 10/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberH7493926232220
Device Catalogue Number39262-3222
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/27/2017
Initial Date FDA Received11/14/2017
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) Hospitalization; Required Intervention;
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