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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC SYNERGY STENT 3.5 X 28 MM

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BOSTON SCIENTIFIC SYNERGY STENT 3.5 X 28 MM Back to Search Results
Lot Number 39260-2835
Device Problems Mechanical Problem (1384); Structural Problem (2506); Difficult to Open or Close (2921)
Patient Problem Chest Tightness/Pressure (2463)
Event Date 12/27/2018
Event Type  Injury  
Event Description

The pt was having percutaneous coronary angioplasty and stenting for cad. As stent was being deployed, it was noted that the stent balloon only inflated to 2 atmospheres of pressure and then complete pressure was lost in the balloon. Physician was unable to withdraw the stent that was lodged in the balloon. It was suspected that the shaft broke in the mid segment and we were unable to remove the balloon or stent. The pt became unstable, surgery consult was obtained and the pt was taken for emergent surgery for two vessel bypass. The stent was left there.

 
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Brand NameSYNERGY STENT 3.5 X 28 MM
Type of DeviceSYNERGY STENT 3.5 X 28 MM
Manufacturer (Section D)
BOSTON SCIENTIFIC
MDR Report Key8290133
MDR Text Key134703452
Report Number8290133
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 01/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device LOT Number39260-2835
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/07/2019
Distributor Facility Aware Date12/27/2018
Event Location Hospital
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/30/2019 Patient Sequence Number: 1
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