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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 10619
Device Problem Failure to Advance (2524)
Patient Problem Chest Pain (1776)
Event Date 11/22/2023
Event Type  Injury  
Event Description
It was reported that procedure was cancelled, chest pain resulting in prolonged hospitalization occurred.Vascular access was obtained via the radial artery.The 85% stenosed, 13mm, concentric, de novo target lesion was located in the non-tortuous and moderately calcified left circumflex artery.After a 6f non-bsc guide catheter was engaged and a 0.016 pt2 guide wire crossed the lesion, pre-dilation was performed with 2.50 x 12mm emerge balloon catheter resulting to 60-70% residual stenosis.A 3.00 x 20 synergy drug-eluting stent was advanced for treatment but failed to cross the lesion.The device was removed, and the procedure was not completed due to this event.The patient was stable post-procedure; however, the patient experienced chest pain resulting in prolonged hospitalization.
 
Event Description
It was reported that procedure was cancelled, chest pain resulting in prolonged hospitalization occurred.Vascular access was obtained via the radial artery.The 85% stenosed, 13mm, concentric, de novo target lesion was located in the non-tortuous and moderately calcified left circumflex artery.After a 6f non-bsc guide catheter was engaged and a 0.016 pt2 guide wire crossed the lesion, pre-dilation was performed with 2.50 x 12mm emerge balloon catheter resulting to 60-70% residual stenosis.A 3.00 x 20 synergy drug-eluting stent was advanced for treatment but failed to cross the lesion.The device was removed, and the procedure was not completed due to this event.The patient was stable post-procedure; however, the patient experienced chest pain resulting in prolonged hospitalization.
 
Manufacturer Narrative
Device evaluated by mfr.: synergy ous mr 3.00 x 20mm stent delivery system was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.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.No issues identified with the hypotube shaft.The outer and inner lumen and tactile examination of the mid-shaft section found no issues.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.
 
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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 Key18861689
MDR Text Key337181559
Report Number2124215-2024-13846
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeMO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number10619
Device Catalogue Number10619
Device Lot Number0030733119
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age80 YR
Patient SexFemale
Patient Weight65 KG
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