• 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
Lot Number 0028825190
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 04/25/2022
Event Type  Injury  
Event Description
It was reported that removal difficulties were encountered and an allergic reaction occurred. Procedure summary: the 70% stenosed target lesion was located in the mildly tortuous and moderately calcified proximal right coronary artery (rca). A 5. 00 x 24mm synergy megatron drug-eluting stent was selected for use in the percutaneous coronary intervention (pci) procedure. The lesion pre dilated with nc balloons. During procedure, the stent was fully deployed at 18 atmospheres without any issues. During removal, the balloon of the stent was entrapped on the struts of the stent and an allergic reaction occurred with the patient. The physician tried to inflate and deflate the balloon a couple of times to remove the balloon but it was unsuccessful. The patient was sent to another hospital. A snare was used to pull the balloon out along with the stent. There were no further patient complications, the patient was stable and fully recovered.
 
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 Key14360729
MDR Text Key291415381
Report Number2134265-2022-05434
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0028825190
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/11/2022 Patient Sequence Number: 1
-
-