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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 Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2022
Event Type  Injury  
Manufacturer Narrative
Initial reporter address: (b)(6).
 
Event Description
It was reported that stent fracture occurred.The 75% stenosed target lesion was located in the non-tortuous and non-calcified left main artery.A 5.00 x 12 synergy drug-eluting stent was advanced for treatment.However, when the stent balloon was inflated, the stent was fractured in the middle.The stent was implanted and the physician completed the procedure by using another stent to cover the fracture.There were no patient complications reported and the patient status was stable.
 
Event Description
It was reported that stent fracture occurred.The 75% stenosed target lesion was located in the non-tortuous and non-calcified left main artery.A 5.00 x 12 synergy drug-eluting stent was advanced for treatment.However, when the stent balloon was inflated, the stent was fractured in the middle.The stent was implanted and the physician completed the procedure by using another stent to cover the fracture.There were no patient complications reported and the patient status was stable.
 
Manufacturer Narrative
E1 initial reporter address 1: (b)(6).Device evaluated by mfr.: (media review) a review of the images provided could not identify the alleged stent fracture however, a gap which could indicate strut displacement was noted in the mid stent region.The distal end of the guide catheter was also noted to be inside the deployed stent in one of the images.The apparent strut displacement noted could have been appeared to the physician as stent fracture however this was not the case as the displaced struts visible in the photo review most likely represent a stent deformation induced by a possible interaction with ancillary devices use during the procedure.This allows the stent to conform (through the 5-connector proximal (first 2 rows) and 2 connectors throughout and in the distal section design to the vessel anatomy and provide the required scaffolding without any straightening of the vessel.Additionally the coplanar view from which we are seeing the stent could mislead to assume that there is a stent fracture when in fact what we are seeing is two strut connectors on the same plane on view (one behind the other), and this would be consistent with the stent image reviewed where struts are displaced in a v shape and connected in a central point.H3 other text : media.
 
Manufacturer Narrative
(e1) initial reporter address 1: (b)(6).Device evaluated by mfr.: (media review) a review of the images provided could not identify the alleged stent fracture however, a gap which could indicate strut displacement was noted in the mid stent region.The distal end of the guide catheter was also noted to be inside the deployed stent in one of the images.The apparent strut displacement noted could have been appeared to the physician as stent fracture however this was not the case as the displaced struts visible in the photo review most likely represent a stent deformation induced by a possible interaction with ancillary devices use during the procedure.This allows the stent to conform (through the 5-connector proximal (first 2 rows) and 2 connectors throughout and in the distal section design to the vessel anatomy and provide the required scaffolding without any straightening of the vessel.Additionally the coplanar view from which we are seeing the stent could mislead to assume that there is a stent fracture when in fact what we are seeing is two strut connectors on the same plane on view (one behind the other), and this would be consistent with the stent image reviewed where struts are displaced in a v shape and connected in a central point.
 
Event Description
It was reported that stent fracture occurred.The 75% stenosed target lesion was located in the non-tortuous and non-calcified left main artery.A 5.00 x 12 synergy drug-eluting stent was advanced for treatment.However, when the stent balloon was inflated, the stent was fractured in the middle.The stent was implanted and the physician completed the procedure by using another stent to cover the fracture.There were no patient complications reported and the patient status was stable.It was further reported that the target lesion was pre-dilated with a 4.0x6mm semi-compliant balloon catheter at 18 atmospheres.Additionally, the stent fracture occurred immediately after deployment and the broken struts were visible under fluoroscopy.
 
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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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13725842
MDR Text Key287112466
Report Number2134265-2022-01831
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIN
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 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/07/2023
Device Model Number10617
Device Catalogue Number10617
Device Lot Number0027681554
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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