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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT Back to Search Results
Lot Number 0032285141
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/12/2023
Event Type  Injury  
Event Description
It was reported that removal difficulty and balloon detachment occurred.The 100% stenosed chronic total occlusion (cto) target lesion was located in the moderately to severely tortuous and mildly calcified right coronary artery.There was a 90-degree bend proximally.An 8f guide with 8f guidezilla were used during the procedure.The cto was opened and ballooned with multiple size balloons.A 3.50 x 48mm synergy xd was advanced for treatment and deployed.The balloon was inflated at 17 atmospheres for 15 seconds and was deflated.However, during the procedure, even though the balloon was fully deflated, the physician had difficulty removing the balloon.When the balloon was pulled back, the balloon detached from the shaft.The shaft was removed but the balloon remained on the wire.After multiple attempts to remove the stent balloon, including blowing up a balloon against the stent balloon and attempting to pull back, the physician was finally able to get the wire and balloon out as one unit.
 
Event Description
It was reported that removal difficulty and balloon detachment occurred.The 100% stenosed chronic total occlusion (cto) target lesion was located in the moderately to severely tortuous and mildly calcified right coronary artery.There was a 90-degree bend proximally.An 8f guide with 8f guidezilla were used during the procedure.The cto was opened and ballooned with multiple size balloons.A 3.50 x 48mm synergy xd was advanced for treatment and deployed.The balloon was inflated at 17 atmospheres for 15 seconds and was deflated.However, during the procedure, even though the balloon was fully deflated, the physician had difficulty removing the balloon.When the balloon was pulled back, the balloon detached from the shaft.The shaft was removed but the balloon remained on the wire.After multiple attempts to remove the stent balloon, including blowing up a balloon against the stent balloon and attempting to pull back, the physician was finally able to get the wire and balloon out as one unit.It was further reported that multiple deflation attempts were made.
 
Manufacturer Narrative
Device evaluated by mfr.Synergy xd mr us 3.50 x 48mm stent delivery system (sds) was returned for analysis.A visual, tactile examination identified multiple kinks along the hypotube shaft.The device was received in two sections as a result of a break in the distal extrusion.The break was located at the guidewire exit port.The distal extrusion was severely stretched.There were multiple kinks along the extrusion.A microscopic examination of the balloon material identified no tears or holes in the balloon.There was blood visible inside the balloon.The stent was deployed during the procedure, from the balloon.A microscopic examination of the bumper tip showed no signs of damage.
 
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Brand Name
SYNERGY XD
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 Key18457148
MDR Text Key332258794
Report Number2124215-2023-73047
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0032285141
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/14/2023
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
GUIDE CATHETER: 8F GUIDEZILLA; GUIDE CATHETER: 8F GUIDEZILLA; GUIDEWIRE: R350; GUIDEWIRE: R350
Patient Outcome(s) Required Intervention;
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