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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 H7493941838300
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2021
Event Type  malfunction  
Event Description
It was reported that there was foreign material present on the device.The target lesion was located in the right coronary artery (rca).A 3.00 x 38mm synergy xd drug-eluting stent was advanced to the distal mid-portion of the rca.The physician then overlapped that stent proximally with a 3.50 x 48mm synergy xd drug-eluting stent.The stents were deployed and the vessel was treated successfully; however, it was noted that there were uncharacteristic bumps on the shafts of the delivery catheters.No patient complications were reported.
 
Manufacturer Narrative
A synergy xd mr ous 3.00 x 38mm stent delivery system was returned for analysis without a stent.No stent was returned as it was deployed at the lesion site.The balloon cones were reviewed via scope, and found to be in a deflated state with folds relaxed.A visual and tactile examination of the hypotube found multiple 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.No foreign material was present on the device.The mid shaft bond was within acceptable visual standards for uv midshaft bond bulge.No other issues were noted with the device.
 
Event Description
It was reported that there was foreign material present on the device.The target lesion was located in the right coronary artery (rca).A 3.00 x 38mm synergy xd drug-eluting stent was advanced to the distal mid-portion of the rca.The physician then overlapped that stent proximally with a 3.50 x 48mm synergy xd drug-eluting stent.The stents were deployed and the vessel was treated successfully; however, it was noted that there were uncharacteristic bumps on the shafts of the delivery catheters.No patient complications were reported.It was further reported that devices were delivered as single units not in tandem.However due to the previous experience prior, both devices were inspected post usage and it was felt that one device had higher profile than the other in the midshaft region.
 
Event Description
It was reported that there was foreign material present on the device.The target lesion was located in the right coronary artery (rca).A 3.00 x 38mm synergy xd drug-eluting stent was advanced to the distal mid-portion of the rca.The physician then overlapped that stent proximally with a 3.50 x 48mm synergy xd drug-eluting stent.The stents were deployed and the vessel was treated successfully; however, it was noted that there were uncharacteristic bumps on the shafts of the delivery catheters.No patient complications were reported.It was further reported that devices were delivered as single units not in tandem.However due to the previous experience prior, both devices were inspected post usage and it was felt that one device had higher profile than the other in the midshaft region.
 
Manufacturer Narrative
B5-updated.
 
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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 Key11309185
MDR Text Key231207014
Report Number2134265-2021-01051
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729981015
UDI-Public08714729981015
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 03/29/2021
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 Date09/28/2022
Device Model NumberH7493941838300
Device Lot Number0026124980
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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