Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
Model Number H7493941816300
Device Problems Entrapment of Device (1212); Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2022
Event Type  malfunction  
Event Description
It was reported that device entrapment occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 3.00 x 16mm synergy xd drug-eluting stent was loaded on a non-boston scientific guidewire but failed to track and ended up getting fused to the guidewire outside of the body.After an unsuccessful attempt to forcefully remove the device from the guidewire, the physician needed to cut the guidewire to get the device off.It was also noted that the stent became damaged.The procedure was completed with another of same device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the synergy xd mr us 3.00 x 16mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found that the stent was deformed and mangled on the balloon.As a result of the condition of the stent it was not possible to measure the stent outer diameter (od).As a result a review was performed into the stent crimp od at the time of production and was within maximum crimped stent profile measurement.It was not possible to examine the balloon due to the damaged stent on the balloon.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual and microscopic examination of the shaft polymer extrusion found to the extrusion to be bunched along its length.As a result of this damage it was not possible to pass a recommended 0.014 inch guidewire through the stretched and bunched lumen.
 
Event Description
It was reported that device entrapment occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 3.00 x 16mm synergy xd drug-eluting stent was loaded on a non-boston scientific guidewire but failed to track and ended up getting fused to the guidewire outside of the body.After an unsuccessful attempt to forcefully remove the device from the guidewire, the physician needed to cut the guidewire to get the device off.It was also noted that the stent became damaged.The procedure was completed with another of same device.No patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYNERGY XD
Type of Device
CORONARY 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
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15824618
MDR Text Key307500448
Report Number2124215-2022-46280
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729980964
UDI-Public08714729980964
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberH7493941816300
Device Lot Number0030046974
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/02/2022
Initial Date FDA Received11/18/2022
Supplement Dates Manufacturer Received12/13/2022
Supplement Dates FDA Received01/03/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/23/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDEWIRE: BMW; GUIDEWIRE: BMW
-
-