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

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.

• Brand Name: SYNERGY STENT 3.5 X 28 MM
• Type of Device: SYNERGY STENT 3.5 X 28 MM
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 8290133
• MDR Text Key: 134703452
• Report Number: 8290133
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 39260-2835
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2019
• Distributor Facility Aware Date: 12/27/2018
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 57 YR