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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 0026543397
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2022
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.A 4.00 x 20mm synergy xd drug-eluting stent was advanced for dilatation.However, during inflation, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no patient complications and the patient was stable.
 
Event Description
It was reported that balloon rupture occurred.A 4.00 x 20mm synergy xd drug-eluting stent was advanced for dilatation.However, during inflation, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no patient complications and the patient was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr ous 4.00 x 20mm stent delivery system was returned for analysis.A visual examination of the stent section found that the stent was not returned for analysis.The balloon was returned in a deflated state with balloon wings relaxed.Crimp markings visible on balloon.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube found no issues along the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found solidified media present inside the inflation lumen.The device was soaked in a water bath at 37 degrees celsius to facilitate functional testing.Encore device was verified before and after use to 16atm.An attempt was made to inflate the device to 16atm as per instructions for use but pressure could not be maintained due to pinhole leak on the distal balloon at the distal markerband.No other issues were identified during the product analysis.
 
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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 Key13905346
MDR Text Key288031033
Report Number2134265-2022-03438
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/01/2022
Device Lot Number0026543397
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2020
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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