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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10619
Device Problems Positioning Problem (3009); Migration (4003)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/16/2019
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent positioning problems were encountered.The target lesion was located in a coronary vessel.A 4.00x20mm synergy drug eluting stent was advanced for treatment.However, it was noted that the stent moved at the moment of its release.Despite this, the stent was successfully deployed and the procedure was completed.No patient complications were reported.
 
Manufacturer Narrative
Device is a combination product.Event: initially reported as positioning placement problem update to migration device code initially report as positioning problem update to migration.
 
Event Description
It was reported that stent migration occurred.The target lesion was located in a coronary vessel.A 4.00x20mm synergy drug eluting stent was advanced for treatment.However, it was noted that the stent moved at the moment of its release.Despite this, the stent was successfully deployed and the procedure was completed.No patient complications were reported.
 
Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: the device was not returned for analysis.One series of angiographic procedural media was provided containing the reported event.The media was reviewed by medical safety.The medical media review conclusion stated that the images provided revealed stent moved during inflation.Potential contributing factors include a size mismatch between stent and the target vessel diameter leading to balloon slippage also known as 'watermelon seeding' or negative tension on the system while pulling the guiding catheter back during deployment inadvertently withdrew the stent delivery system during balloon inflation.
 
Event Description
It was reported that stent migration occurred.The target lesion was located in a coronary vessel.A 4.00x20mm synergy drug eluting stent was advanced for treatment.However, it was noted that the stent moved at the moment of its release.Despite this, the stent was successfully deployed and the procedure was completed.No patient complications were reported.
 
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Brand Name
SYNERGY
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8631115
MDR Text Key145744402
Report Number2134265-2019-05142
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 06/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/13/2020
Device Model Number10619
Device Catalogue Number10619
Device Lot Number0023225013
Was Device Available for Evaluation? No
Date Manufacturer Received05/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age54 YR
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