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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 0026884393
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2021
Event Type  malfunction  
Event Description
It was reported that removal difficulties and stent damage occurred.The target lesion was located within the coronary artery.A 5.00 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the balloon became stuck on the deployed stent and was difficult to remove.Physician inflated and deflated the balloon multiple times for 30 seconds.Deflation issues were noted and the balloon remained stuck on the stent.The balloon was pulled with force and crunched the distal edge of the stent.The stent was left in place deformed and no additional treatment.No patient complications were reported.
 
Event Description
It was reported that removal difficulties and stent damage occurred.The target lesion was located within the coronary artery.A 5.00 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the balloon became stuck on the deployed stent and was difficult to remove.Physician inflated and deflated the balloon multiple times for 30 seconds.Deflation issues were noted and the balloon remained stuck on the stent.The balloon was pulled with force and crunched the distal edge of the stent.The stent was left in place deformed and no additional treatment.No patient complications were reported.It was further reported that the stent was fully deployed and well apposed except for the distal edge where no balloon would pass.The physician had difficulty deflating the balloon but eventually, the balloon deflates.The patient was stable.
 
Manufacturer Narrative
(e1)removed initial reporter first name.(e1) updated initial reporter last name.(e3) occupation corrected from other health care professional- technician to physician.Synergy xd mr us 5.00 x 28 mm stent delivery system was returned for analysis.A visual examination of the stent found no stent on the sds.The crimped stent outer diameter was within maximum crimped stent profile measurement.The balloon was returned in a deflated state.A visual and microscopic examination of the bumper tip showed signs of distal tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks on several locations of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found an inner shaft polymer extrusion damage at 7.9 cm proximal to distal tip.The device was placed in water-bath to soften the hardened media at 37 degrees celsius.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied but pressure could not be sustained due to leak at the damaged site on the shaft polymer extrusion (inflation liquid noted coming out of the tip).Encore device verified before and after use using the druck gauge at 18 atmospheres.No other issues were identified during 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
MDR Report Key12170075
MDR Text Key261662375
Report Number2134265-2021-09027
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/16/2023
Device Lot Number0026884393
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2021
Date Manufacturer Received07/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age59 YR
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