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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
Lot Number 0025308565
Device Problems Failure to Advance (2524); Material Deformation (2976); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address 1: (b)(6).
 
Event Description
It was reported that stent damage occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.The lesion was prepared using a rotablator followed by pre-dilatation with a balloon catheter resulting in a 75% residual stenosis.A 2.25 x 28mm synergy xd drug-eluting stent was advanced but failed to cross the lesion.The device was removed and it was confirmed that the tip was lifted.Further dilatation was performed with a cutting balloon and the procedure was completed with another of same device.No patient complications nor injuries were reported.
 
Manufacturer Narrative
E1: initial reporter address 1: (b)(6).H6 device codes: corrected from "material deformation" to "material integrity problem.".
 
Event Description
It was reported that stent damage occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.The lesion was prepared using a rotablator followed by pre-dilatation with a balloon catheter resulting in a 75% residual stenosis.A 2.25 x 28mm synergy xd drug-eluting stent was advanced but failed to cross the lesion.The device was removed and it was confirmed that the tip was lifted.Further dilatation was performed with a cutting balloon and the procedure was completed with another of same device.No patient complications nor injuries were reported.However, it was further reported that it was distal tip of the catheter that lifted and not the stent itself.
 
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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 Key12249454
MDR Text Key264260928
Report Number2134265-2021-09800
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 08/03/2021
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 Expiration Date02/23/2022
Device Lot Number0025308565
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/20/2021
Initial Date FDA Received07/29/2021
Supplement Dates Manufacturer Received07/25/2021
Supplement Dates FDA Received08/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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