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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
Device Problems Difficult to Remove (1528); Material Integrity Problem (2978); Failure to Deflate (4060)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/01/2023
Event Type  malfunction  
Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.
 
Event Description
It was reported that balloon deflation failure occurred, and removal difficulties were encountered.A synergy drug-eluting stent was advanced for treatment.However, during the procedure, the balloon did not deflate well and could not be withdrawn into the guide.The entire system had to be removed and restart again.Upon external inspection, the balloon was crimped asymmetrically.No patient complications were reported.
 
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Brand Name
SYNERGY
Type of Device
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key17054594
MDR Text Key316476361
Report Number2124215-2023-27879
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeNZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/11/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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