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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 Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/29/2020
Event Type  malfunction  
Event Description
It was reported that removal difficulty was encountered.The target lesion was located in the mildly tortuous left anterior descending artery.After pre-dilation, a 2.25 x 20mm synergy xd drug-eluting stent was advanced for treatment.The device was inflated and the stent was expanded at 11 atmospheres.When the stent was expanded, the indeflator was released to deflate the balloon.However, it was noticed that the balloon did not deflate.Several attempts were made to reinflate and deflate the balloon as to try to release the balloon from the stent.The doctor rotated and pulled the catheter in an attempt to dislodge the balloon from the stent with success.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: a synergy xd mr us 2.25 x 20mm stent delivery system was returned for analysis without the stent and with a stopcock valve attached to the manifold.Stent was not returned as it was positioned and deployed at the lesion site.The balloon cones were reviewed, and the balloon appeared in a partially inflated state with clear hard liquid noted inside and crimp markings evident on the balloon wall.The balloon folds were partially opened and not fully flattened.A visual and microscopic examination of the bumper tip showed distal tip damage.A visual and tactile examination of the hypotube found no issues.The manifold and hub visual examination found no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.The device was placed in water bath overnight for soaking pre-inflation test due dried liquid inside.Following soaking, the device was loaded onto a 0.014" guide wire and loaded into a test guide catheter without issue.The balloon was inflated with no issues and balloon folds clearly flattened following test deflation.Vacuum was pulled and the balloon deflated in 08 seconds with no issues.The encore inflation device was verified before and after use.No other issues were identified during the product analysis.
 
Event Description
It was reported that removal difficulty was encountered.The target lesion was located in the mildly tortuous left anterior descending artery.After pre-dilation, a 2.25 x 20mm synergy xd drug-eluting stent was advanced for treatment.The device was inflated and the stent was expanded at 11 atmospheres.When the stent was expanded, the indeflator was released to deflate the balloon.However, it was noticed that the balloon did not deflate.Several attempts were made to reinflate and deflate the balloon as to try to release the balloon from the stent.The doctor rotated and pulled the catheter in an attempt to dislodge the balloon from the stent with success.No patient complications were 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
MDR Report Key11163720
MDR Text Key226583481
Report Number2134265-2021-00116
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729980735
UDI-Public08714729980735
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/08/2022
Device Model NumberH7493941820220
Device Lot Number0025600473
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2021
Initial Date Manufacturer Received 01/04/2021
Initial Date FDA Received01/13/2021
Supplement Dates Manufacturer Received02/04/2021
Supplement Dates FDA Received02/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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