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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 0032263714
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2024
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.The target lesion was located in a mildly tortuous and moderately calcified coronary artery.A 4.00 x 28mm synergy xd drug eluting stent was advanced for treatment.However, it was noted that the shaft broke during insertion.The device was removed and completed the procedure with another synergy stent.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 4.00 x 28mm stent delivery system was returned for analysis.Visual, tactile and microscopic analysis were performed on the device.A visual and tactile examination of the hypotube found multiple kinks along the shaft and also a shaft break at 26cm distal to the distal end of the strain relief.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.Examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.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.Bumper tip showed no signs of distal tip damage.No other device issues were identified during returned product analysis.
 
Event Description
It was reported that shaft break occurred.The target lesion was located in a mildly tortuous and moderately calcified coronary artery.A 4.00 x 28mm synergy xd drug eluting stent was advanced for treatment.However, it was noted that the shaft broke during insertion.The device was removed and completed the procedure with another synergy stent.There were no patient complications 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
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18570238
MDR Text Key333557643
Report Number2124215-2024-02463
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 02/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0032263714
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/20/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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