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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 10607
Device Problem Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 08/31/2020
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.The 75% stenosed target lesion was located in the mildly tortuous and mildly calcified mid to distal right coronary artery.A 4.00 x 38 synergy drug-eluting stent was selected for use.However, upon removing the stylet and sheath, resistance was felt and it was noted that the stent was damaged.There were missing struts in the mid to distal section of the stent.The procedure was completed with another of the same device.
 
Event Description
It was reported that stent damage occurred.The 75% stenosed target lesion was located in the mildly tortuous and mildly calcified mid to distal right coronary artery.A 4.00 x 38 synergy drug-eluting stent was selected for use.However, upon removing the stylet and sheath, resistance was felt and it was noted that the stent was damaged.There were missing struts in the mid to distal section of the stent.The procedure was completed with another of the same device.
 
Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 4.00 x 38 stent delivery system catheter was returned for analysis.A visual examination of the stent found stent damage.Stent struts on the 5th and 6th proximal rows were lifted and bunched distally.All stent struts were present.The undamaged stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.No other issues were identified during the product analysis.
 
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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 Key10497659
MDR Text Key205925118
Report Number2134265-2020-12349
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729840435
UDI-Public08714729840435
Combination Product (y/n)N
PMA/PMN Number
P150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/15/2021
Device Model Number10607
Device Catalogue Number10607
Device Lot Number0024666504
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2020
Date Manufacturer Received10/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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