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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 0029656975
Device Problems Material Rupture (1546); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2023
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The patient presented with ischemic heart disease and was being treated for percutaneous coronary intervention (pci).The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending artery.A 3.00 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, when the balloon was inflated at 11 atmospheres for 5 seconds, the balloon ruptured, and contrast media was leaking.Additionally, upon pulling out the balloon, the stent got deformed.The stent delivery system was removed successfully and completed the procedure.There were no patient complications nor injuries reported.
 
Manufacturer Narrative
E1: initial reporter first name: updated.E1: initial reporter last name: (b)(6).
 
Event Description
It was reported that balloon rupture occurred.The patient presented with ischemic heart disease and was being treated for percutaneous coronary intervention (pci).The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending artery.A 3.00 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, when the balloon was inflated at 11 atmospheres for 5 seconds, the balloon ruptured, and contrast media was leaking.Additionally, upon pulling out the balloon, the stent got deformed.The stent delivery system was removed successfully and completed the procedure.There were no patient complications nor injuries reported.
 
Manufacturer Narrative
E1: initial reporter last name: corrected from (b)(6) to (b)(6).Device evaluated by mfr.: synergy xd mr ous 3.00 x 20mm stent delivery system was returned for analysis.The device was returned without the stent attached.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture was within maximum crimped stent profile specification.The balloon was reviewed, and it was found to be in a partially deflated state with blood like substance visible.A pinhole was visible under microscopic inspection during inflation attempts.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues.Encore device verified before and after use using the druck gauge to 16 atm as per instructions for use (ifu).Device attempted to be inflated to rbp 16 atm however pressure could not be maintained in the inflation device due to leak at the distal balloon cone.No other issues were identified during the product analysis.
 
Event Description
It was reported that balloon rupture occurred.The patient presented with ischemic heart disease and was being treated for percutaneous coronary intervention (pci).The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending artery.A 3.00 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, when the balloon was inflated at 11 atmospheres for 5 seconds, the balloon ruptured, and contrast media was leaking.Additionally, upon pulling out the balloon, the stent got deformed.The stent delivery system was removed successfully and completed the procedure.There were no patient complications nor injuries reported.
 
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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
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16604625
MDR Text Key312012290
Report Number2124215-2023-10972
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeJA
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 04/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0029656975
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2022
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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