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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10611
Device Problem Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/13/2021
Event Type  malfunction  
Event Description
It was reported that a markerband issue was encountered.A 2.75 x 20 synergy drug-eluting stent was implanted to treat the target lesion.However, the physician stated that the femoral markers on the shaft of the stent were switched.The procedure was completed with no patient complications reported.
 
Manufacturer Narrative
The device was not returned however two photos were received attached to the complaint record.The first photo shows an opened foil packing of this synergy device with the second photo showing an image of the device shaft.Sdc manufacturing reviewed the photos and confirmed that the 100 cm and 90 cm white hot stamp markers on the shaft are switched in position (2 markers located at the 90 cm instead of 1 and 1 marker located at 100 cm instead of 2).H3 other text : photos.
 
Event Description
It was reported that a markerband issue was encountered.A 2.75 x 20 synergy drug-eluting stent was implanted to treat the target lesion.However, the physician stated that the femoral markers on the shaft of the stent were switched.The procedure was completed with no patient complications reported.
 
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Brand Name
SYNERGY
Type of Device
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12555624
MDR Text Key274069429
Report Number2134265-2021-11963
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729840640
UDI-Public08714729840640
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
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/06/2023
Device Model Number10611
Device Catalogue Number10611
Device Lot Number0027136417
Was Device Available for Evaluation? No
Date Manufacturer Received10/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age73 YR
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