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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 10623
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/19/2022
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.The patient presented for percutaneous coronary intervention.The de novo target lesion with no significant bend was located in the non-tortuous vessel.After obtaining vascular access via the radial artery, a 2.75 x 38 synergy drug-eluting stent was advanced for treatment.However, during the procedure, the shaft broke outside the patient approximately 30 cm from the hub.The procedure was completed with another synergy drug-eluting stent.There were no patient complications reported and the patient condition was fine.
 
Event Description
It was reported that shaft break occurred.The patient presented for percutaneous coronary intervention.The de novo target lesion with no significant bend was located in the non-tortuous vessel.After obtaining vascular access via the radial artery, a 2.75 x 38 synergy drug-eluting stent was advanced for treatment.However, during the procedure, the shaft broke outside the patient approximately 30 cm from the hub.The procedure was completed with another synergy drug-eluting stent.There were no patient complications reported and the patient condition was fine.
 
Manufacturer Narrative
E1: updated initial reporter title, first name, last name, email.E1: initial reporter facility name: corrected from (b)(6) medical center.E1: initial reporter city: corrected from (b)(6).E1: initial reporter country: corrected from united states to israel.E2: health professional: corrected from no to yes.E3: occupation: updated to physician.
 
Event Description
It was reported that shaft break occurred.The patient presented for percutaneous coronary intervention.The de novo target lesion with no significant bend was located in the non-tortuous vessel.After obtaining vascular access via the radial artery, a 2.75 x 38 synergy drug-eluting stent was advanced for treatment.However, during the procedure, the shaft broke outside the patient approximately 30 cm from the hub.The procedure was completed with another synergy drug-eluting stent.There were no patient complications reported and the patient condition was fine.
 
Manufacturer Narrative
(b)(6).Device evaluated by mfr.: synergy ous mr 2.75 x 38mm stent delivery system 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 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 distal tip damage.A visual and microscopic examination of the hypotube shaft found multiple kinks and a hypotube break 20.5cm distal to the strain relief.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during analysis.
 
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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 Key16054033
MDR Text Key308025016
Report Number2124215-2022-54219
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 02/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10623
Device Catalogue Number10623
Device Lot Number0029647586
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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