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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
Device Problems Entrapment of Device (1212); Material Deformation (2976)
Patient Problems Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059)
Event Date 03/12/2019
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent damage occurred.A rotalink plus 1.5mm selected for use in the distal right coronary artery (rca) after a rotawire extra support was placed in the lesion.The target lesion was approximately 20mmx3.0mm with mild tortuosity and severe calcification.The burr was unable to cross inside the pre-placed synergy stent from the stent proximal part, so it was advanced by dynaglide, and ablation was performed once.It started at 155000rpm, and decrease a maximum of 3000rpm.During the second ablation, it started at 150,000rpm and decrease to 120,000rpm, and then, the stall lamp was displayed.The burr became stuck in the distal rca.St elevation of the avf, 2 and 3 occurred along with a decrease in blood pressure.Another non-bsc guidewire was inserted.When the burr was pulled, it was released from being stuck.Visual inspection of the device once removed revealed that the pre-placed synergy stent was damaged and stuck to the shaft.Poba was performed by 2mm, and ivus checking was performed.Poba was again performed by 3.0, and non-bsc stent was placed in the rca distal.A synergy 3.5x38 was placed in the rca proximal.After that, poba was performed inside each stent.The procedure was completed without checking final ivus.The patient entered the ccu on that day without using assisted circulation.The patient's current condition is good.The physicians comment regarding the possible cause of the burr becoming stuck in the lesion was as follows.It was likely due that to the rotational burr interacted with the drug-eluting stent (des) that already placed in the lesion.It could also be a contributor that endosporium tissue was not yet sufficiently constructed as des was just placed about a month before this procedure.
 
Event Description
It was reported that stent damage occurred.A rotalink plus 1.5mm selected for use in the distal right coronary artery (rca) after a rotawire extra support was placed in the lesion.The target lesion was approximately 20mmx3.0mm with mild tortuosity and severe calcification.The burr was unable to cross inside the pre-placed synergy stent from the stent proximal part, so it was advanced by dynaglide, and ablation was performed once.It started at 155000rpm, and decrease a maximum of 3000rpm.During the second ablation, it started at 150,000rpm and decrease to 120,000rpm, and then, the stall lamp was displayed.The burr became stuck in the distal rca.St elevation of the avf, 2 and 3 occurred along with a decrease in blood pressure.Another non-bsc guidewire was inserted.When the burr was pulled, it was released from being stuck.Visual inspection of the device once removed revealed that the pre-placed synergy stent was damaged and stuck to the shaft.Poba was performed by 2mm, and ivus checking was performed.Poba was again performed by 3.0, and non-bsc stent was placed in the rca distal.A synergy 3.5x38 was placed in the rca proximal.After that, poba was performed inside each stent.The procedure was completed without checking final ivus.The patient entered the ccu on that day without using assisted circulation.The patient's current condition is good.The physicians comment regarding the possible cause of the burr becoming stuck in the lesion was as follows.It was likely due that to the rotational burr interacted with the drug-eluting stent (des) that already placed in the lesion.It could also be a contributor that endosporium tissue was not yet sufficiently constructed as des was just placed about a month before this procedure.
 
Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: a stent was returned for analysis.A visual examination of the returned stent found the stent located on the distal end of a rotablator 1.50mm device.There was severe damage along the entire length of the stent, and the stent was attached to the shaft of the rotablator with no possible movement.No other parts of the device were returned for analysis.
 
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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 Key8501207
MDR Text Key141514774
Report Number2134265-2019-03725
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,distri
Type of Report Initial,Followup
Report Date 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2019
Date Manufacturer Received05/07/2019
Patient Sequence Number1
Patient Outcome(s) Other;
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