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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 0025250818
Device Problems Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/28/2020
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.This synergy xd 2.25 x 16mm was selected for a procedure.It was reported there was severe resistance when tracking the device through the extension catheter and the distal part of the stent became damaged.The procedure was completed with a different device with no adverse effects or injuries for the patient.
 
Event Description
It was reported that stent damage occurred.This synergy xd 2.25 x 16mm was selected for a procedure.It was reported there was severe resistance when tracking the device through the extension catheter and the distal part of the stent became damaged.The procedure was completed with a different device with no adverse effects or injuries for the patient.It was further reported that the target lesion had a slight bend, was severely calcified and pre-dilatation was performed.The synergy stent became caught in the collar of the size 6f extension catheter.
 
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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 Key10436993
MDR Text Key203878123
Report Number2134265-2020-10234
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/09/2022
Device Lot Number0025250818
Was Device Available for Evaluation? No
Date Manufacturer Received08/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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