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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
Model Number 10622
Device Problems Material Rupture (1546); Device-Device Incompatibility (2919); Activation Failure (3270); Migration (4003)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/15/2019
Event Type  Injury  
Manufacturer Narrative
Device is combination product.
 
Event Description
It was reported that stent migration occured.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 3.50 x 32 synergy drug-eluting stent was implanted for treatment.However, during procedure, it was noted that the stent strut was caught and migration occurred.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient status is stable.
 
Manufacturer Narrative
Device is combination product.Updated to adverse event and product problem.Device evaluated by mfr.: synergy ous mr 3.50 x 32mm stent delivery system was returned for analysis.The stent was not returned with the stent delivery system as it was used during the procedure.The balloon had the appearance of having been inflated.The returned device was loaded onto a mandrel and attached to an encore inflation unit.Positive pressure was applied, and the balloon was successfully inflated to its rate of burst pressure of 16 atmospheres (atm) with no leaks or drops in pressure noted.The pressure was held for 30 seconds, this was recorded with digital timer.The inflation device was verified at 16 atm, before and after use with a calibrated pressure gauge.This inflation to rate of burst pressure of 16 atm was repeated three times and with no issues or drop in pressure noted.A visual and microscopic examination of the balloon material identified no issues that could have contributed to the complaint incident.A visual and tactile examination of the hypotube found multiple kinks.A visual and tactile examination of the shaft polymer extrusion identified inner polymer extrusion stretching 186mm distal of the port weld which extended for 2mm.A viscual and microscopic examination found no issues with the tip.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent migration occured.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 3.50 x 32 synergy drug-eluting stent was implanted for treatment.However, during procedure, it was noted that the stent strut was caught and migration occurred.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient status is stable.It was further reported that when the stent was implanted in the patient, the balloon ruptured and the stent strut was partially unextended due to severe calcium.Interference occurred when the second stent passed under the first stent strut.Migration occurred at the edge of the strut of the first stent in the vessel.The physician finished the procedure by overlapping the first stent with an additional stent.
 
Manufacturer Narrative
Device is combination product.B1: updated to adverse event and product problem.
 
Event Description
It was reported that stent migration occured.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 3.50 x 32 synergy drug-eluting stent was implanted for treatment.However, during procedure, it was noted that the stent strut was caught and migration occurred.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient status is stable.It was further reported that when the stent was implanted in the patient, the balloon ruptured and the stent strut was partially unextended due to severe calcium.Interference occurred when the second stent passed under the first stent strut.Migration occurred at the edge of the strut of the first stent in the vessel.The physician finished the procedure by overlapping the first stent with an additional stent.
 
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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 Key8804884
MDR Text Key151508453
Report Number2134265-2019-08457
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,foreig
Type of Report Initial,Followup,Followup
Report Date 09/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/22/2019
Device Model Number10622
Device Catalogue Number10622
Device Lot Number0022327756
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2019
Date Manufacturer Received08/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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