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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 10617
Device Problems Break (1069); Difficult to Insert (1316); Premature Activation (1484); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/24/2022
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.The patient presented with ischemic cardiopathy.The target lesion was located in the proximal left anterior descending artery.A 4.00 x 12mm synergy drug eluting stent was advanced for treatment.However, during introduction, the device was fractured at the distal part.It was noted that the device was a bit expanded at the time of pulling out its shaft and just before its insertion into the guidezilla ii extension catheter making insertion impossible.The device was removed and the procedure completed with a different device.There were no patient complications.
 
Manufacturer Narrative
H6 device codes: corrected.
 
Event Description
It was reported that shaft break occurred.The patient presented with ischemic cardiopathy.The target lesion was located in the proximal left anterior descending artery.A 4.00 x 12mm synergy drug eluting stent was advanced for treatment.However, during introduction, the device was fractured at the distal part.It was noted that the device was a bit expanded at the time of pulling out its shaft and just before its insertion into the guidezilla ii extension catheter making insertion impossible.The device was removed and the procedure completed with a different device.There were no patient complications.It was further reported that the stent was a bit expanded but the stent struts were in one single piece as usual.The shaft was in good condition and was not broken as what was previously reported.
 
Manufacturer Narrative
H6 device codes: corrected.The synergy ous mr 4.00 x 12mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent outer diameter was measured 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 signs of damage.A visual and tactile examination of the hypotube found multiple hypotube kinks at several locations along the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found no issues.No other issues were identified during the product analysis.
 
Event Description
It was reported that shaft break occurred.The patient presented with ischemic cardiopathy.The target lesion was located in the proximal left anterior descending artery.A 4.00 x 12mm synergy drug eluting stent was advanced for treatment.However, during introduction, the device was fractured at the distal part.It was noted that the device was a bit expanded at the time of pulling out its shaft and just before its insertion into the guidezilla ii extension catheter making insertion impossible.The device was removed and the procedure completed with a different device.There were no patient complications.It was further reported that the stent was a bit expanded but the stent struts were in one single piece as usual.The shaft was in good condition and was not broken as what was previously reported.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key14282022
MDR Text Key290692928
Report Number2134265-2022-04953
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeMX
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,Followup
Report Date 07/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2023
Device Model Number10617
Device Catalogue Number10617
Device Lot Number0027982216
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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