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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 Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2023
Event Type  malfunction  
Event Description
It was reported that stent failed to expand occurred.The stenosed target lesion was located in the severely calcified left circumflex artery.A 3.00 x 12 synergy ii drug-eluting stent was advanced for treatment.However, during deployment of the device, the stent failed to expand.The device was removed, and the procedure was cancelled.There were no additional intervention, patient complications or injuries reported and patient condition was stable.
 
Manufacturer Narrative
E1 initial reported phone: (b)(6).
 
Manufacturer Narrative
E1 initial reported phone: (b)(6).Device evaluated by mfr.Synergy ous mr stent delivery system (sds) was returned for analysis.Visual examination identified the stent struts flared at the proximal end of the stent.No issues identified with the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Bumper tip showed no signs of distal tip damage.Microscopic examination of the crimped stent via scope found evidence of stent struts flared at the proximal end of the stent.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.No signs of movement, stent was set between the proximal and distal markerbands.Stent struts were flared at the proximal end of the stent.Bumper tip showed no signs of distal tip damage.Dimensional testing of stent profile: the undamaged crimped stent od (outer diameter) was measured, and the result was within max crimped stent profile measurement.No other device issues were identified during returned product analysis.
 
Event Description
It was reported that stent failed to expand occurred.The stenosed target lesion was located in the severely calcified left circumflex artery.A 3.00 x 12 synergy ii drug-eluting stent was advanced for treatment.However, during deployment of the device, the stent failed to expand.The device was removed, and the procedure was cancelled.There were no additional intervention, patient complications or injuries reported and patient condition was stable.
 
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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 Key19034270
MDR Text Key339283558
Report Number2124215-2024-19433
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeCH
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 05/22/2024
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 Expiration Date05/24/2024
Device Model Number10617
Device Catalogue Number10617
Device Lot Number0029556801
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/13/2024
Initial Date FDA Received04/03/2024
Supplement Dates Manufacturer Received04/26/2024
Supplement Dates FDA Received05/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/25/2022
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 Age70 YR
Patient SexMale
Patient Weight85 KG
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