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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 UNK776
Device Problem Occlusion Within Device (1423)
Patient Problems Chest Pain (1776); ST Segment Elevation (2059); Thrombosis (2100)
Event Date 02/04/2017
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 medwatch will be filed. (b)(4).
 
Event Description
It was reported that chest pain, st segment elevation and stent thrombosis occurred. At the start of procedure, the patient was given with heparin. A synergy¿ drug-eluting stent was implanted to treat the lesion. However, after the patient was taken to the holding room, the patient started having chest pain and within minutes of arrival from the catheterization laboratory, electrocardiogram showed st segment elevation. The patient was brought back to the catheterization laboratory and it was found out that the implanted stent was completely closed off. The physician then performed parallel replacement of the oxygenator not transferring oxygen (pronto) and ballooning. The procedure was completed and the patient was discharged at a later date. No further patient complications were reported and the patient's status was good.
 
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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 Key6351865
MDR Text Key68083039
Report Number2134265-2017-01416
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK776
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 Received02/06/2017
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 Treatment Data
Date Received: 02/22/2017 Patient Sequence Number: 1
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