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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 10603
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Thrombosis (2100)
Date of Event 10/31/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device is combination product.
 
Event or Problem Description
It was reported that stent thrombosis occurred.A 2.50 x 20 synergy stent was used to perform intervention of the ramus.The physician used heparin (8000 units) during the procedure.Before the patient came off the procedure table, the patient became symptomatic and had to be re-cathed and revealed thrombus in the stent.The physician "peformed" thrombectomy, ballooning, and gave aggrastat.The procedure was completed with no further complications.
 
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Brand Name
SYNERGY
Common Device Name
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8282793
Report Number2134265-2019-00468
Device Sequence Number18867343
Product Code NIQ
UDI-Device Identifier08714729840152
UDI-Public08714729840152
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
P150003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date06/25/2020
Device Model Number10603
Device Catalogue Number10603
Device Lot Number0022329837
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/07/2019
Initial Report FDA Received Date01/28/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Weight126
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