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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 10603
Device Problems Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
 
Event Description
It was reported that stent damage occurred.The target lesion was located in the vein graft.Following pre-dilatation of a 2.5mm balloon catheter, a non-bsc guide extension catheter was introduced and a 4 x 20 synergy drug-eluting stent (des) was advanced but it failed to deliver.When the device was removed, it was noticed that the stent struts were damaged.Pre-dilatation was performed again with a 3.0 balloon catheter and advanced a new synergy des and the procedure was completed.No patient complications were reported.
 
Manufacturer Narrative
D3 model number udpted from unknown to 10603.Lot number updated from unknown to 0024612501.Catalog number updted from unknown to 10603.Expiration date updated from unknown to 10/06/2021.Unique identifier (udi) updated from unknown to #(b)(4).H4 device manufacture date updated from unknown to 10/07/2019.Device evaluated by mfr.: a synergy ii us mr 4.00 x 20mm stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.Stent struts in the mid-section of the stent lifted and damaged.The undamaged stent outer diameter 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 issues.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.A 0.014" guidewire, verified with snap gauge, loaded successfully through the distal end of the tip and exited at the exchange port without issue.No other issues were identified during the product analysis.B3 date of event: used the first date of the month of the aware date as no event date was provided.
 
Event Description
It was reported that stent damage occurred.The target lesion was located in the vein graft.Following pre-dilatation of a 2.5mm balloon catheter, a non-bsc guide extension catheter was introduced and a 4 x 20 synergy drug-eluting stent (des) was advanced but it failed to deliver.When the device was removed, it was noticed that the stent struts were damaged.Pre-dilatation was performed again with a 3.0 balloon catheter and advanced a new synergy des and the procedure was completed.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 Key10381140
MDR Text Key202085837
Report Number2134265-2020-09720
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 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/06/2021
Device Model Number10603
Device Catalogue Number10603
Device Lot Number0024612501
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2020
Date Manufacturer Received09/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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