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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 Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/03/2020
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent damage occurred.An ffr was performed with a boston scientific comet ii pressure guidewire and the ffr result was positive.The back end handle was removed from the comet ii pressure guidewire so it could be used as the interventional wire.A 2.25 x 16 synergy stent was loaded onto the backend of the guidewire.While loading the device, the wire slipped and caused one of the stent struts to become damaged.The proximal stent strut was sticking up.The stent was set aside and the procedure was completed with another of the same device.The case was finished without any further complications.
 
Manufacturer Narrative
Device evaluated by mfr: a 2.25 x 16mm synergy ii stent delivery system was returned for analysis.A visual examination of the stent found that stent struts at the distal end of the stent were lifted and pulled proximally.The undamaged section of the crimped stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.Stent damage most likely occurred when the stent interacted with the guidewire during loading of the guidewire attempts.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 tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force that could have been applied on the delivery system.A visual and tactile examination of the outer and mid shaft section and visual examination of the inner extrusion shaft found multiple kinks along several locations along the shaft polymer extrusion.This type of damage is consistent with excessive force that could have been applied on the delivery system.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent damage occurred.An ffr was performed with a boston scientific comet ii pressure guidewire and the ffr result was positive.The back end handle was removed from the comet ii pressure guidewire so it could be used as the interventional wire.A 2.25 x 16 synergy stent was loaded onto the backend of the guidewire.While loading the device, the wire slipped and caused one of the stent struts to become damaged.The proximal stent strut was sticking up.The stent was set aside and the procedure was completed with another of the same device.The case was finished without any further complications.
 
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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 Key10471034
MDR Text Key204894220
Report Number2134265-2020-11978
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729840084
UDI-Public08714729840084
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 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/27/2021
Device Model Number10602
Device Catalogue Number10602
Device Lot Number0024372803
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2020
Date Manufacturer Received09/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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