• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON CORONARY DRUG-ELUTING STENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493942828500
Device Problems Deflation Problem (1149); Material Separation (1562); Obstruction of Flow (2423)
Patient Problem Discomfort (2330)
Event Date 06/28/2021
Event Type  Injury  
Event Description
It was reported that the balloon failed to deflate and the balloon detached and dislodged inside the patient. The target lesion was located in right coronary artery. A non-bsc embolic protection filter was advanced to the lesion but failed to cross. The lesion was then pre-dilated with a 2. 0mm emerge balloon catheter and the non-bsc embolic protection filter was able to be deployed distally to the lesion. A 5. 00 x 32mm synergy megatron was successfully deployed. Then a 5. 00 x 28mm synergy megatron balloon expandable stent was successfully deployed. The balloon of the stent delivery system was then fully deflated and was pulled proximally to post-dilate the proximal portion of the deployed 5. 00 x 28mm synergy megatron. After the post dilation, the balloon would not fully deflate. An endoflator was utilized, the stopcock was closed, and double negative pressure was applied. The balloon was then slightly inflated and attempted to be deflated while gently pulling on the stent delivery system. The balloon then detached from the delivery system. The semi inflated balloon remained in the saphenous vein graft. The severely damaged stent delivery system was then removed without the balloon attached. A series of wires, balloons, snares, and dual access devices were used in attempts to retrieve dislodged balloon. The patient was placed on a balloon pump and was being prepared for surgery. The physician was then able to retrieve the non-bsc embolic protection filter and the dislodged balloon. The patient did not have to go to surgery. The saphenous vein graft had open flow and the patient pain decreased. The procedure was completed and there were no further patient complications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNERGY MEGATRON
Type of DeviceCORONARY DRUG-ELUTING STENT
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 Key12165829
MDR Text Key261452681
Report Number2134265-2021-08957
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/07/2021
Device Model NumberH7493942828500
Device Lot Number0026502747
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2020
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: 07/14/2021 Patient Sequence Number: 1
-
-