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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 02/07/2017
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 and stent thrombosis occurred. The patient presented with inferior st-segment elevation myocardial infarction (stemi). The target lesion was located in the distal right coronary artery (rca). After pre-dilatation with a 2. 5x12mm emerge balloon catheter, a 3. 0x20mm synergy¿ drug-eluting stent was deployed to treat the lesion. Post-dilatation was performed with a 3. 5x12mm emerge balloon catheter and the procedure was completed. However, the following day, the patient returned with chest pain and inferior st-segment elevation. The physician found that the previously implanted 3. 0x20mm synergy¿ stent was occluded. Subsequently, the lesion was dilated and a 3. 0x32mm synergy¿ stent was deployed in the distal rca and a 3. 0x20 synergy¿ stent was deployed in the mid rca. Post-dilatation was performed with a 3. 5 nc emerge balloon catheter and the procedure was completed. No further complications were reported, the patient's status was well, and the patient was returned to the cardiac unit.
 
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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 Key6351932
MDR Text Key68082918
Report Number2134265-2017-01358
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 02/07/2017
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 Received02/07/2017
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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