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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
Device Problems Fracture (1260); Difficult to Advance (2920)
Patient Problem Restenosis (4576)
Event Date 12/01/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.(b)(6).
 
Event Description
It was reported that in-stent restenosis and stent fracture occurred.The target lesion was a previously implanted synergy stent in the ostium of the right coronary artery (rca).The stent restenosed and appeared fractured.Under angiography it appeared that the implanted synergy extended into the aorta and that the proximal to mid portion of the synergy appeared to be disfigured and fractured.The stent damage may have occurred during implantation, in the physician opinion.The physician attempted to engage the rca and wire the synergy with a workhorse coronary wire.The wire would not tract through the synergy and into the mid/distal portion of the rca.The case was abandoned and further consultation with other interventionalists will occur to plan a treatment option for the patient.No further patient complications were reported.
 
Manufacturer Narrative
D6a: implant date: around (b)(6) 2020.B3: date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.E1: initial reporter facility name - (b)(6).
 
Event Description
It was reported that in-stent restenosis and stent fracture occurred.The target lesion was a previously implanted synergy stent in the ostium of the right coronary artery (rca).The stent restenosed and appeared fractured.Under angiography it appeared that the implanted synergy extended into the the aorta and that the proximal to mid portion of the synergy appeared to be disfigured and fractured.The stent damage may have occurred during implantation, in the physician opinion.The physician attempted to engage the rca and wire the synergy with a workhorse coronary wire.The wire would not tract through the synergy and into the mid/distal portion of the rca.The case was abandoned and further consultation with other interventionalists will occur to plan a treatment option for the patient.No further patient complications were reported.It was further reported that the target lesion was ostial right coronary artery (rca).The the lesion was prepared.The stent restenosed and appeared fractured occurred within 12 months of implant.In the physician opinion, the stent damaged most likely occurred during the original implantation of the synergy by the guide catheter the patient was stable post angiogram.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13112732
MDR Text Key282963100
Report Number2134265-2021-16247
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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