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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

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BOSTON SCIENTIFIC CORPORATION SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10606
Device Problem Fracture (1260)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 09/09/2020
Event Type  Injury  
Event Description

It was reported that stent fracture occurred. The target lesion was located in the moderately calcified left main into the left anterior descending artery. A 3. 00 x 32 synergy drug eluting stent was advanced for treatment and successfully deployed. However, after intravascular ultrasound was used together with an enhance stent visualization tool, it was noted that the stent was fractured. Subsequently, a second layer of stent was implanted to cover the fracture and the procedure was completed. There were no patient complications reported.

 
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Brand NameSYNERGY
Type of DeviceBIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10627969
MDR Text Key209841807
Report Number2134265-2020-12953
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/05/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number10606
Device Catalogue Number10606
Device LOT Number0024976109
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 Received10/15/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/18/2019
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: 10/05/2020 Patient Sequence Number: 1
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