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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
Model Number H7493941820220
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/22/2021
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The 100% occluded target lesion was located in the moderately tortuous and moderately calcified proximal diagonal artery.A 2.25 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, when attempted to pull negative on balloon, the blood goes back in and found the balloon was burst after removal.The procedure was completed with another of the same device.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.25 x 20mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found no evidence of any damage.The crimped stent outer diameter was measured using snap gauge and the result was within maximum crimped stent profile measurement.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 microscopic examination of the balloon area identified no tears or holes in the balloon material.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 a shaft break at 35 cm proximal to the distal end of the tip in the lasercut region, in the midshaft extrusion.The device was soaked in a water bath at 37 degrees celsius in order to soften any solidified media inside the device.A 0.014inch guidewire was inserted through the tip and wire lumen with no restrictions noted.An attempt to inflate the balloon to its rated burst pressure (rbp) of 18 atmospheres (atm) identified a leak at the break in the extrusion at the lasercut region.The device was cut at the break site and an inflation aid was used to facilitate the inflation of the balloon.Using an encore inflation device, the balloon was inflated to rbp, held pressure and deflated in 8 seconds and the stent deployed without issues.The encore device was verified before and after use using the druck gauge to 18 atm.No other issues were identified during the product analysis.
 
Event Description
It was reported that balloon rupture occurred.The 100% occluded target lesion was located in the moderately tortuous and moderately calcified proximal diagonal artery.A 2.25 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, when attempted to pull negative on balloon, the blood goes back in and found the balloon was burst after removal.The procedure was completed with another of the same device.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
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 Key12757793
MDR Text Key280588358
Report Number2134265-2021-13931
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729980735
UDI-Public08714729980735
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 12/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/06/2023
Device Model NumberH7493941820220
Device Lot Number0027142016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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