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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 10602
Device Problems Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2018
Event Type  malfunction  
Manufacturer Narrative
Device is combination product.
 
Event Description
It was reported that stent damage occurred.The target lesion was located in the mildly calcified left main artery into the proximal left anterior descending artery.At the course of the procedure, the physician used a 3.75 mach 1 8fr lbu guide catheter, a guidezilla ii guide extension catheter, samurai guide wire, a non-bsc guide wire, multiple balloon inflations and a choice pt guide wire.Subsequently, a 4.00 x 16mm synergy stent was advanced but failed to cross the lesion.However, it was noted that the stent had damage to the struts which was noted on the proximal stent edge.Another synergy 4.00 x 16 stent was advanced but it aslo failed to cross the lesion.The procedure was completed with a 4.0 x 8mm and a 4.0 x12mm synergy stents.No patient complications were reported.
 
Manufacturer Narrative
Device is combination product.Lot number updated from unknown to 0022618540.Expiration date updated from unknown to 08/28/2020.Unique identifier (udi) # updated from unknown to (b)(4).
 
Event Description
It was reported that stent damage occurred.The target lesion was located in the mildly calcified left main artery into the proximal left anterior descending artery.At the course of the procedure, the physician used a 3.75 mach 1 8fr lbu guide catheter, a guidezilla ii guide extension catheter, samurai guide wire, a non-bsc guide wire, multiple balloon inflations and a choice pt guide wire.Subsequently, a 4.00 x 16mm synergy stent was advanced but failed to cross the lesion.However, it was noted that the stent had damage to the struts which was noted on the proximal stent edge.Another synergy 4.00 x 16 stent was advanced but it aslo failed to cross the lesion.The procedure was completed with a 4.0 x 8mm and a 4.0 x12mm synergy stents.No patient complications were 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 Key8181470
MDR Text Key130998483
Report Number2134265-2018-64451
Device Sequence Number1
Product Code NIQ
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 01/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/28/2020
Device Model Number10602
Device Catalogue Number10602
Device Lot Number0022618540
Was Device Available for Evaluation? No
Date Manufacturer Received12/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDE CATHETER: MACH 18 FR LBU 3.75; GUIDE CATHETER: MACH 18 FR LBU 3.75; GUIDE EXTENSION CATHETER: GUIDEZILLA II; GUIDE EXTENSION CATHETER: GUIDEZILLA II; GUIDE WIRE: SAMURAI, SAMURAI, CHOICE PT; GUIDE WIRE: SAMURAI, SAMURAI, CHOICE PT
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