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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 10604
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033)
Event Date 11/01/2020
Event Type  Injury  
Event Description
It was reported that an allergic reaction was suspected. On (b)(6) 2020, a 2. 25 x 24 synergy stent was advanced and deployed at the target lesion. The procedure was completed and no patient complications resulted in relation to this event. In (b)(6) 2020, following the procedure and within 30 days of the stent implant, the patient broke out in a rash and experienced shortness of breath. The rash was noted to come and go and appeared as a round red circle, which itched and was sometimes painful. No further patient complications were reported in relation to this event.
 
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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 Key11856424
MDR Text Key251725940
Report Number2134265-2021-06584
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729840206
UDI-Public08714729840206
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 05/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/02/2022
Device Model Number10604
Device Catalogue Number10604
Device Lot Number0025010373
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/20/2021 Patient Sequence Number: 1
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