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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493941812270
Device Problems Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2021
Event Type  malfunction  
Event Description
It was reported that there was foreign material present in device.The target lesion was located in the left anterior descending artery.A 2.75 x 12mm synergy xd drug eluting stent was selected for use.However, there was a clear plastic/glue nub on the distal end of the stent delivery catheter.The catheter got caught in the sheath and could not be delivered.The procedure was completed with another of the same device.There were no patient complications reported.
 
Manufacturer Narrative
Updated b5: describe event or problem.
 
Event Description
It was reported that there was foreign material present in device.The target lesion was located in the left anterior descending artery.A 2.75 x 12mm synergy xd drug eluting stent was selected for use.However, there was a clear plastic/glue nub on the distal end of the stent delivery catheter.The catheter got caught in the sheath and could not be delivered.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that the device had difficulty in loading into 5fr guide catheter.It was caught in the hub and the catch point was the midshaft bond.
 
Event Description
It was reported that there was foreign material present in device.The target lesion was located in the left anterior descending artery.A 2.75 x 12mm synergy xd drug eluting stent was selected for use.However, there was a clear plastic/glue nub on the distal end of the stent delivery catheter.The catheter got caught in the sheath and could not be delivered.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that the device had difficulty in loading into 5fr guide catheter.It was caught in the hub and the catch point was the midshaft bond.
 
Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.75 x 12mm stent delivery system was returned for analysis.Examination of the crimped stent via scope found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon cones were reviewed via scope, and no issues were noted.The balloon wings were tightly wrapped and evenly folded.The balloon had not been subjected to positive pressure.A visual and tactile examination of the hypotube identified mutltple hypotube kinks.Examination of the tip via scope found no damage to the tip.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and tactile examination.Necking/ kinking of the shaft polymer extrusion was noted 34cm proximal to the distal end of the tip.Measurements of the mid shaft bond were performed.For visual reference purpose a synergy xd catheter batch (3.50/16mm lot 26768345-037) was used to compare reference mid shaft bond and complaint midshaft bond for visual purpose.Mid shaft bond was not acceptable as per visual standard specifications.No foreign material was present on the device.Device to device interaction was performed with a 0.014" guide wire loaded into a test 5f guide catheter.The complaint device was loaded onto the guide wire and inserted into the 5f guide catheter, however, the device could not pass into the guide catheter due to the raised mid shaft bond.No other issues were noted with the device.
 
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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 Key11309013
MDR Text Key231203721
Report Number2134265-2021-00921
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729980872
UDI-Public08714729980872
Combination Product (y/n)Y
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 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/12/2022
Device Model NumberH7493941812270
Device Lot Number0026227270
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2021
Date Manufacturer Received03/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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