• 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 XD 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 XD CORONARY DRUG-ELUTING STENT Back to Search Results
Lot Number 0026884393
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2021
Event Type  malfunction  
Event Description
It was reported that removal difficulties and stent damage occurred. The target lesion was located within the coronary artery. A 5. 00 x 28mm synergy xd drug-eluting stent was advanced for treatment. However, during the procedure, the balloon became stuck on the deployed stent and was difficult to remove. Physician inflated and deflated the balloon multiple times for 30 seconds. Deflation issues were noted and the balloon remained stuck on the stent. The balloon was pulled with force and crunched the distal edge of the stent. The stent was left in place deformed and no additional treatment. No patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNERGY XD
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 Key12170075
MDR Text Key261662375
Report Number2134265-2021-09027
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
Report Date 08/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0026884393
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-