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; 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; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10621
Device Problem Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/18/2020
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.4.50 x 28mm and 4.50 x 24mm synergy ii drug-eluting stents were unable to pass through a 6f guidezilla guide catheter and was damaged.No patient complications were reported.
 
Manufacturer Narrative
H6 - evaluation conclusion codes: corrected from adverse event related to procedure d1002 to failure to follow instructions d1101.Device evaluated by mfr.: synergy ii us mr 4.50 x 28mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage.The struts along the distal end were lifted and pulled distally.The undamaged crimped stent outer diameter was measured and the result is within maximum crimped stent profile measurement.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.A visual examination of the bumper tip showed signs of damage.A visual examination of the bumper tip showed signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual 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 damage occurred.4.50 x 28mm and 4.50 x 24mm synergy ii drug-eluting stents were unable to pass through a 6f guidezilla guide catheter and was damaged.No patient complications were reported.
 
Event Description
It was reported that stent damage occurred.4.50 x 28mm and 4.50 x 24mm synergy ii drug-eluting stents were unable to pass through a 6f guidezilla guide catheter and was damaged.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 4.50 x 28mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage.The struts along the distal end were lifted and pulled distally.The undamaged crimped stent outer diameter was measured and the result is within maximum crimped stent profile measurement.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.A visual examination of the bumper tip showed signs of damage.A visual examination of the bumper tip showed signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYNERGY
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11235546
MDR Text Key228869876
Report Number2134265-2021-00824
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729973386
UDI-Public08714729973386
Combination Product (y/n)N
PMA/PMN Number
P150003/S039
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 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/19/2021
Device Model Number10621
Device Catalogue Number10621
Device Lot Number0024844512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2021
Date Manufacturer Received02/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-