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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10621
Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/29/2020
Event Type  malfunction  
Event Description
It was reported that stent was difficult to view under fluoroscopy.The 78% stenosed target lesion was located in the non-tortuous and severely calcified left anterior descending artery.A 3.50 x 28 synergy ii drug-eluting stent was advanced for treatment.However, during deployment, the stent strut appears unclear under fluoroscopy making it difficult to find good stent placement before inflation of the stent within the vessel.The stent was successfully deployed without any issues.No patient complications were reported and the patient status was stable.
 
Event Description
It was reported that stent was difficult to view under fluoroscopy.The 78% stenosed target lesion was located in the non-tortuous and severely calcified left anterior descending artery.A 3.50 x 28 synergy ii drug-eluting stent was advanced for treatment.However, during deployment, the stent strut appears unclear under fluoroscopy making it difficult to find good stent placement before inflation of the stent within the vessel.The stent was successfully deployed without any issues.No patient complications were reported and the patient status was stable.It was further reported that no device issue was noted but a possible x-ray equipment/radiation issue that caused the difficulty viewing the stent under fluoroscopy.
 
Manufacturer Narrative
B5 describe event or problem updated.
 
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Brand Name
SYNERGY
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10862844
MDR Text Key217172062
Report Number2134265-2020-16029
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,foreig
Type of Report Initial,Followup
Report Date 12/15/2020
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 Date04/27/2022
Device Model Number10621
Device Catalogue Number10621
Device Lot Number0025517053
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/31/2020
Initial Date FDA Received11/18/2020
Supplement Dates Manufacturer Received12/03/2020
Supplement Dates FDA Received12/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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