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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 Problem Migration or Expulsion of Device
Event Date 07/26/2018
Event Type  Injury  
Manufacturer Narrative

Device is a combination product.

 
Event Description

It was reported that stent explantation occurred. The target lesion was located in the severely calcified left anterior descending (lad) artery. Following pre-dilatation, a 4. 00 x 20 synergy drug-eluting stent was implanted in the mid lad, followed by the implantation of a 4. 00 x 28 synergy drug-eluting stent in the proximal lad. However, it was noted that the proximal lad stent was malapposed and the two stents became stuck. During removal of the proximal lad stent, it got caught in the mid lad stent and both stents were removed from the patient. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable.

 
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Brand NameSYNERGY
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI 
Manufacturer Contact
sonali arangil
two scimed place
maple grove , MN 55311
6515827403
MDR Report Key7814231
Report Number2134265-2018-60245
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 08/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/05/2019
Device MODEL Number10619
Device Catalogue Number10619
Device LOT Number0021874493
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 Received07/30/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/09/2018
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: 08/24/2018 Patient Sequence Number: 1
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