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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT Back to Search Results
Device Problem Obstruction of Flow (2423)
Patient Problems Restenosis (4576); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2022
Event Type  Injury  
Event Description
It was reported that in-stent restenosis occurred.On an unknown date, a synergy stent was implanted in the mildly tortuous right coronary artery (rca).On (b)(6) 2022, the synergy stent was found to have 99% in-stent re-stenosis (isr).The rca was fibrotic.A 4.00 x 20mm synergy xd drug-eluting stent was introduced for treatment.However, as the device was being advanced down the artery, it was noted that the stent was coming off the balloon.The physician pulled the device back into the guide catheter and tried to remove the entire system together.When they got to the sheath, they realized the stent was left in the radial artery.The physician advanced a wire from the sheath through the stent and performed a cut down and snare to retrieve.The procedure was completed with different a device.There were no patient complications reported.
 
Event Description
It was reported that in-stent restenosis occurred.On an unknown date, a synergy stent was implanted in the mildly tortuous right coronary artery (rca).On (b)(6) 2022, the synergy stent was found to have 99% in-stent re-stenosis (isr).The rca was fibrotic.A 4.00 x 20mm synergy xd drug-eluting stent was introduced for treatment.However, as the device was being advanced down the artery, it was noted that the stent was coming off the balloon.The physician pulled the device back into the guide catheter and tried to remove the entire system together.When they got to the sheath, they realized the stent was left in the radial artery.The physician advanced a wire from the sheath through the stent and performed a cut down and snare to retrieve.The procedure was completed with different a device.There were no patient complications reported.
 
Manufacturer Narrative
H6 patient codes and h6 impact codes: corrected.
 
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Brand Name
SYNERGY XD
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key14025064
MDR Text Key288698049
Report Number2134265-2022-03933
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/14/2022
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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