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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 10620
Device Problems Break (1069); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2023
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.The target lesion was located in the moderately calcified vessel.A 2.50 x 24 synergy drug-eluting stent was advanced for treatment.However, during the procedure, unusual force tension was felt while advancing the stent delivery system (sds) into the lesion.After multiple unsuccessful attempts, the entire system was withdrawn, and it was noted that the shaft was break.The device was removed intact, and the procedure was completed with a non-boston scientific device.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr: synergy ous mr 2.50 x 24mm drug-eluting stent was returned for analysis.A visual, microscopic and tactile examination of the hypotube shaft identified a break at 23cm distal to the distal end of the strain relief.Multiple hypotube kinks identified in various locations along the length of the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.There was no sign of damage, stretching or lifting of the stent struts.No signs of movement, stent was set between the proximal and distal markerbands.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.The device could be loaded on a 0.014 inches test guidewire without issues.
 
Event Description
It was reported that shaft break occurred.The target lesion was located in the moderately calcified vessel.A 2.50 x 24 synergy drug-eluting stent was advanced for treatment.However, during the procedure, unusual force tension was felt while advancing the stent delivery system (sds) into the lesion.After multiple unsuccessful attempts, the entire system was withdrawn, and it was noted that the shaft was break.The device was removed intact, and the procedure was completed with a non-boston scientific device.There were no patient complications reported.
 
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Brand Name
SYNERGY
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18423237
MDR Text Key331911756
Report Number2124215-2023-74205
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodePE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10620
Device Catalogue Number10620
Device Lot Number0030193925
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/11/2023
Initial Date FDA Received01/01/2024
Supplement Dates Manufacturer Received02/16/2024
Supplement Dates FDA Received02/23/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
BALLOON CATHETER USED: SEMICOMPLAINT, 2.50MM; BALLOON CATHETER USED: SEMICOMPLAINT, 2.50MM; GUIDE-CATHETER USED: CONVEY 6F; GUIDE-CATHETER USED: CONVEY 6F
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