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 H7493941816220
Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2020
Event Type  malfunction  
Event Description
It was reported that stent dislodgment occurred.A 2.25 x 16mm synergy xd drug-eluting stent was selected for use.There was no indication of damage upon removing the device from the package and when removed from the plastic hoop.However, when the physician removed the stylet, the stent came off the balloon and was stuck half way in and half way out at the proximal end of the stent protector.The procedure was completed with another stent.
 
Event Description
It was reported that stent dislodgment occurred.A 2.25 x 16mm synergy xd drug-eluting stent was selected for use.There was no indication of damage upon removing the device from the package and when removed from the plastic hoop.However, when the physician removed the stylet, the stent came off the balloon and was stuck half way in and half way out at the proximal end of the stent protector.The procedure was completed with another stent.It was further reported that they encountered difficulty in removing the stent protector and the product mandrel.The stent was stuck in the distal end of protector when it completely separated from the balloon catheter.
 
Manufacturer Narrative
A synergy xd mr us 2.25 x 16mm stent delivery system was returned for analysis.The stent was returned inside the stent protector detached from the device.The stent was damaged the whole length with struts squashed and some struts stretched.The product mandrel was not returned.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Crimp markings were visible on the exposed balloon wall.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent dislodgment occurred.A 2.25 x 16mm synergy xd drug-eluting stent was selected for use.There was no indication of damage upon removing the device from the package and when removed from the plastic hoop.However, when the physician removed the stylet, the stent came off the balloon and was stuck half way in and half way out at the proximal end of the stent protector.The procedure was completed with another stent.It was further reported that they encountered difficulty in removing the stent protector and the product mandrel.The stent was stuck in the distal end of protector when it completely separated from the balloon catheter.
 
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
MDR Report Key11149292
MDR Text Key226119847
Report Number2134265-2020-18634
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729980728
UDI-Public08714729980728
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/09/2022
Device Model NumberH7493941816220
Device Lot Number0026047681
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2021
Date Manufacturer Received02/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-